Clinical Research Jobs in Bangalore

Why This Role MattersClinical trials are essential for evaluating the safety, efficacy, and quality of new medicines before they reach patients. Drug-based clinical trials require strict monitoring, accurate documentation, and compliance with international regulatory guidelines to ensure reliable research outcomes. Monitoring clinical trial sites helps maintain data integrity, participant safety, and regulatory compliance throughout the study lifecycle.The Clinical Research Monitor plays a critical role in supervising clinical trial activities at research sites. This role ensures that clinical trials are conducted according to study protocols, Good Clinical Practice (GCP) guidelines, and regulatory requirements. By coordinating with investigators, research staff, and sponsors, the monitor ensures that clinical trial processes—from site feasibility to study closeout are performed correctly.At St. John’s Research Institute (SJRI), Bengaluru, the Clinical Research Monitor position supports the TIPS‑3 PHRI Study, a drug-based clinical trial focused on advancing medical research and improving patient outcomes. Professionals in this role contribute significantly to maintaining the quality, safety, and scientific validity of the clinical trial.Job DescriptionThe Clinical Research Monitor will support ongoing clinical trials by coordinating site activities, assisting senior research staff, and monitoring study progress across clinical trial sites. The role includes conducting monitoring visits, providing training to site staff on GCP and study protocols, and ensuring that all trial activities follow regulatory guidelines.The selected candidate will be involved in multiple phases of the clinical trial lifecycle, including site feasibility assessment, initiation visits, participant recruitment monitoring, follow-up phases, and study closeout activities. The role also requires handling audit readiness and supporting inspection processes to ensure compliance with international clinical research standards.Key Features of the Role• Job Title: Clinical Research Monitor (CRM) / Clinical Trial Monitor• Project Type: Drug-Based Clinical Trial• Research Organization: St. John’s Research Institute• Study: TIPS‑3 PHRI Study• Number of Vacancies: 1• Job Location: Bangalore, India• Work Nature: Clinical trial monitoring and site coordination• Travel Requirement: Willingness to travel to clinical trial sitesResponsibilities• Assisting senior researchers in coordinating and monitoring clinical trial activities.• Undergoing training on clinical trial monitoring processes and regulatory requirements.• Scheduling monitoring visits to ensure compliance with study protocols.• Conducting monitoring visits at clinical trial sites to assess study progress.• Providing training to site staff on Good Clinical Practice (GCP) guidelines and study procedures.• Supporting documentation and data verification to maintain study accuracy.• Ensuring clinical trial activities comply with regulatory and ethical standards.• Coordinating with investigators and clinical staff during the recruitment phase of the study.• Monitoring follow-up activities and participant progress throughout the trial.• Supporting study closeout activities and documentation review.Specific Clinical Trial Activities• Site Feasibility Assessment• Site Initiation Visits• Participant Recruitment Phase Monitoring• Follow-Up Phase Coordination• Study Closeout Phase Activities• For-Cause Monitoring Visits• Audit and Regulatory Inspection SupportRequired QualificationsEducational Requirements• MBBS (Bachelor of Medicine and Bachelor of Surgery)• BVSc (Bachelor of Veterinary Science)• BDS (Bachelor of Dental Surgery)• MPHW with Postgraduate Degree• Graduate or Postgraduate degree with a Diploma in Clinical Research• Integrated postgraduate degrees in relevant healthcare or life sciences disciplinesExperience and Skills• Minimum 2 years of experience working as a Site Clinical Research Associate (CRA) or similar clinical research role.• Understanding of clinical trial monitoring and regulatory compliance.• Knowledge of Good Clinical Practice (GCP) guidelines and clinical trial processes.• Ability to coordinate clinical trial site activities effectively.• Strong analytical and documentation skills.• Willingness to travel for site monitoring visits.• Ability to work collaboratively with clinical investigators and research staff.Language RequirementsCandidates should have proficiency in multiple languages, including:• English, Kannada, Hindi, Tamil, Telugu, Other relevant local languagesSalary InsightsThe salary for the Clinical Research Monitor position is competitive and depends on the candidate’s experience and interview performance.Estimated Salary: • ₹50,000 per monthAdditional professional benefits may include:• Hands-on experience in drug-based clinical trials• Exposure to clinical trial monitoring and site management• Opportunities to work with experienced clinical research professionals• Career growth opportunities within clinical research organizationsCompany OverviewSt. John’s Research Institute (SJRI) is a leading biomedical research institution based in Bangalore, India. The institute conducts research in public health, clinical medicine, nutrition, infectious diseases, and chronic disease prevention.SJRI collaborates with national and international research organizations to conduct high-quality clinical trials and health studies. The institute is recognized for its contributions to improving healthcare outcomes through evidence-based research and scientific innovation. Through studies such as the TIPS‑3 PHRI Study, SJRI supports the advancement of clinical research and contributes to global healthcare improvements.FAQs1. What does a Clinical Research Monitor do?A Clinical Research Monitor supervises clinical trial sites to ensure studies follow protocols, regulatory guidelines, and Good Clinical Practice standards.2. What experience is required for this role?Candidates typically need at least two years of experience as a Site Clinical Research Associate (CRA) or in clinical trial monitoring roles.3. Is travel required for this job?Yes, clinical research monitors usually travel to different trial sites to conduct monitoring visits.4. What skills are important for a Clinical Research Monitor?Important skills include clinical trial knowledge, GCP compliance, communication skills, documentation accuracy, and problem-solving ability.5. What career growth opportunities exist after this role?Professionals can advance to roles such as Senior Clinical Research Associate, Clinical Trial Manager, or Clinical Operations Manager.Application Tips• Highlight experience in clinical trial monitoring or site coordination.• Demonstrate knowledge of Good Clinical Practice (GCP) and clinical trial processes.• Mention any experience with site visits, monitoring reports, or audit preparation.• Emphasize communication skills and the ability to coordinate with multiple research teams.• Include certifications or diplomas related to clinical research if applicable.

Why This Role MattersClinical trials require precise financial management to ensure investigators and research sites are compensated accurately and on time. The Investigator Grants Specialist plays a critical role in managing investigator payments, developing site budgets, and ensuring financial transparency across clinical trial operations.By coordinating with project management and clinical operations teams, this role helps maintain smooth financial workflows, ensuring that investigator grants, site budgets, and payment processes comply with contractual agreements and regulatory standards.At Novotech, this role directly contributes to the success of global clinical trials by supporting accurate budgeting, payment tracking, and operational efficiency across multiple research sites.Job DescriptionThe Investigator Grants Specialist supports the project team in managing investigator payments and developing investigator grants using industry-standard systems such as Grant Plan. The role involves close collaboration with project managers, clinical operations teams, and study teams to ensure timely delivery of site budget templates and quarterly site payments.This position requires strong analytical abilities and organizational skills to manage financial aspects of clinical trials, including investigator payment tracking, grant development, and system management within CTMS platforms.All activities must be conducted in accordance with company Standard Operating Procedures (SOPs), client guidelines, and industry regulations to ensure compliance and accuracy in financial processes related to clinical research studies.Key Features of the RoleThis role offers exposure to financial management in clinical research while working with cross-functional teams responsible for trial execution. The position combines financial analysis, system management, and operational coordination to ensure investigator grants and payments are handled efficiently.Professionals in this role gain hands-on experience with CTMS platforms, grant planning systems, and clinical trial budgeting, making it an excellent opportunity for individuals interested in clinical trial operations, finance, and research management.Responsibilities• Review, update and track investigator payments within CTMS systems to ensure accurate records.• Route correspondence appropriately and ensure queries are assigned to the correct team members in a timely manner.• Escalate payment delays or issues when necessary to maintain timely investigator payments.• Review payments against visit data in CTMS to ensure accuracy and compliance with investigator contracts.• Communicate with Project Managers regarding payment inquiries and manage expectations regarding payment timelines.• Support clinical staff in executing accurate and timely investigator payments as per contractual agreements.• Maintain payment schedules for patient visit reimbursements based on sponsor and site contracts.• Process site payments for patient visits and ensure accuracy before submission.• Review site payment reports to ensure accuracy before processing financial transactions.• Prepare investigator payment reports for study status meetings as requested by project managers.• Ensure each assigned study is properly set up and maintained within investigator payment systems.• Analyze and assess Subject Visit Tracking (SVT) requirements based on study complexity.• Create site SVT templates based on Clinical Trial Research Agreements (CTRAs).• Set up master or site-specific SVT templates within CTMS platforms according to project timelines.• Follow company processes and maintain quality standards while performing investigator payment activities.• Participate in clinical operations meetings and contribute to process improvements and SOP development.• Maintain professional communication with external stakeholders including sponsors and research sites.Investigator Grants Activities• Develop investigator grants using industry-standard grant management systems.• Review clinical study protocols and collaborate with project managers to develop accurate investigator budgets.• Deliver investigator grant documents in a timely and accurate manner.• Provide preliminary budget estimates for clients when requested.• Apply industry standards of care when creating budget models for clinical trials.• Address questions related to Fair Market Value (FMV) during budget development.• Communicate with vendors to resolve system-related issues.• Manage and maintain user access lists for relevant systems.• Track finalized investigator budgets and generate reports as required.Required QualificationsEducational RequirementsCandidates must possess a minimum of the following educational qualifications:• Bachelor’s degree in Life Sciences• Degree in Pharmacy or a related healthcare field• Other relevant biomedical or scientific qualifications may also be consideredExperience and Skills• 12–36 months of experience in a Clinical Research Organization (CRO) or similar environment.• Experience in investigator payment processing within clinical trials.• Familiarity with Clinical Trial Management Systems (CTMS) such as Veeva.• Experience working with Grant Plan systems for investigator grant management.• Understanding of Subject Visit Tracking within CTMS platforms.• Strong proficiency in Microsoft Excel and PowerPoint.• Excellent analytical and problem-solving skills.• Strong verbal and written communication skills.• Good negotiation and stakeholder management abilities.• Excellent interpersonal and relationship-building skills.• High level of organization and attention to detail.• Ability to manage multiple tasks while meeting strict deadlines.• Prior experience within pharmaceutical, CRO, or healthcare industries is preferred.Salary Insights• Additional benefits may include performance incentives, health insurance, flexible work arrangements, and professional development programs.Company OverviewNovotech is a global full-service clinical Contract Research Organization (CRO) headquartered in Sydney, Australia. The company provides clinical development services to pharmaceutical and biotechnology companies across Asia-Pacific, North America, and Europe. With over 34 offices worldwide and thousands of site partnerships, Novotech supports clinical trials across all phases of drug development. The organization offers services such as regulatory submissions, data management, statistical analysis, safety monitoring, medical writing, and clinical operations support. Novotech is known for maintaining high quality and security standards, including ISO 27001 certification for information security management and ISO 9001 certification for quality management systems.FAQs1. What does an Investigator Grants Specialist do?An Investigator Grants Specialist manages investigator budgets and payments during clinical trials to ensure sites are compensated accurately and on time.2. What systems are commonly used in this role?Common systems include CTMS platforms such as Veeva, Grant Plan systems, and Microsoft Excel for financial tracking.3. What industries hire for this role?Pharmaceutical companies, biotechnology firms, and Contract Research Organizations (CROs) commonly hire professionals for investigator grants and clinical trial finance roles.4. What career growth opportunities are available?Professionals can progress to roles such as Clinical Trial Budget Manager, Clinical Operations Manager, or Grants & Contracts Manager.Application Tips• Highlight experience in clinical trial payments, investigator grants, or financial operations within CRO environments.• Emphasize familiarity with CTMS platforms such as Veeva and grant management systems.• Demonstrate strong analytical skills and proficiency in Excel for financial tracking.• Showcase communication skills for coordinating with project managers and study teams.• Mention experience in pharmaceutical, CRO, or healthcare industry environments.

Why This Role MattersThe Investigator Support Assistant plays a vital role in ensuring smooth coordination between global clinical research teams and investigator sites. In clinical trials, timely communication, documentation accuracy, and compliance with regulatory standards directly impact patient safety and study success. This position supports Global Investigator Support (GIS) functions by managing site communication, resolving operational queries, and coordinating documentation and logistics processes. By ensuring patient safety remains the top operational priority and maintaining workflow efficiency, this role contributes significantly to high-quality clinical trial execution and global regulatory compliance.Job DescriptionThe Investigator Support Assistant supports global clinical research operations by assisting investigator sites, coordinating documentation, managing logistics processes, and resolving workflow-related issues. The role involves regular communication with investigator sites, tracking documentation, supporting portal access, handling shipping coordination, and ensuring adherence to Standard Operating Procedures (SOPs). This position is ideal for life sciences and pharmacy graduates seeking entry-level opportunities in clinical research operations, global investigator services, and site management within a multinational CRO environment.Key Features of the Role:• Direct exposure to global clinical trial workflows• Interaction with international investigator sites• Hands-on experience in site support and logistics coordination• Opportunity to work within a compliance-driven environment• Structured training and career development programs• Entry-level opportunity in clinical research operations• Strong foundation for future roles in clinical operations and pharmacovigilanceResponsibilities• Communicate with investigator sites through email and assigned communication platforms• Escalate patient safety concerns promptly to appropriate teams• Assist investigator sites with portal login access and system-related queries• Notify sites regarding specimen pending arrival reports• Compile and distribute communication related to new policies and procedural updates• Prepare airway bills and shipping documentation for site logistics• Coordinate with internal departments to resolve delivery errors• Maintain and update investigator database records• Investigate and resolve simple to moderate system hold issues• Respond to project-related queries within defined timelines• Escalate unresolved concerns to assigned global coordinators• Document service issues and ensure proper resolution• Review and comply with Standard Operating Procedures (SOPs)• Maintain training documentation and compliance records• Track workflow metrics and ensure timely reporting• Participate in onboarding and mandatory corporate training• Attend departmental meetings and continuous learning sessions• Support administrative tasks related to global investigator coordinationRequired QualificationsCandidates should possess an academic background in Life Sciences, Pharmacy, Biotechnology, Microbiology, Clinical Research, or related disciplines. Fresh graduates with strong communication skills and an interest in clinical research operations are encouraged to apply. Candidates with up to two years of experience in clinical operations or site coordination may also be considered.Educational Requirements:• B.Pharm or M.Pharm• B.Sc or M.Sc in Life Sciences, Biotechnology, Microbiology, or related fields• Clinical Research graduates• Equivalent qualifications in health sciences or allied disciplinesExperience and Skills:• 0–2 years of experience in clinical research or healthcare operations• Strong written and verbal communication skills• Basic understanding of clinical trial processes and workflows• Ability to manage documentation accurately and efficiently• Proficiency in MS Office applications• Ability to prioritize tasks and manage multiple responsibilities• Strong attention to detail and compliance awareness• Good problem-solving and query-handling skills• Team-oriented mindset with the ability to work in a global environment• Professional communication skills suitable for international coordinationSalary InsightsThe estimated salary range for this position in the Bangalore market is approximately ₹3,00,000 to ₹4,80,000 per annum (CTC), depending on qualifications, communication skills, and prior experience. In addition to base compensation, employees may receive structured training, performance-based growth opportunities, and exposure to global clinical operations processes.Company OverviewThe hiring organization is a globally recognized life sciences company providing comprehensive drug development, laboratory, and clinical research services. With operations across multiple countries, the organization supports pharmaceutical and biotechnology companies in conducting safe, efficient, and compliant clinical trials. The company emphasizes diversity, inclusion, regulatory excellence, and professional development, offering employees a dynamic environment for long-term career growth in clinical research and healthcare services.FAQsQ1. Is this role suitable for freshers?Yes, fresh graduates with strong communication skills and an interest in clinical research are eligible to apply.Q2. Is prior clinical research experience mandatory?No, prior experience is not mandatory, but basic knowledge of clinical trial processes is beneficial.Q3. What kind of exposure does this role provide?The role offers exposure to global investigator coordination, logistics management, documentation workflows, and compliance-driven operations.Q4. What career growth opportunities are available?Employees may progress to roles such as Clinical Operations Coordinator, Project Support Associate, Site Management Associate, or Pharmacovigilance Associate.Q5. Is this an office-based role?The role is typically office-based in Bangalore, depending on organizational policies.Application Tips• Highlight communication skills and documentation accuracy in your resume• Mention any academic projects or internships related to clinical research• Demonstrate understanding of SOP compliance and workflow management• Showcase proficiency in MS Office and database handling• Prepare examples of multitasking and problem-solving during interviews• Emphasize willingness to learn and adapt to global processes

Why This Role MattersClinical research projects require strong coordination, structured planning, and efficient documentation to ensure successful execution within timelines and regulatory frameworks. A Project Associate plays a critical support role in maintaining operational efficiency, communication flow, and compliance across clinical development programs.At ICON plc, a globally recognized healthcare intelligence and clinical research organization, this position contributes directly to shaping the future of clinical development. The role supports project managers and clinical operations teams, ensuring that administrative and operational activities are executed accurately and on time. For professionals with 1–3 years of experience in Project Management and Clinical Operations, this opportunity provides structured growth within a global CRO environment.Job DescriptionICON plc is seeking a Project Associate with 1 to 3 years of experience in Project Management and Clinical Operations (ClinOps), along with working knowledge of CTMS and eTMF systems. The selected candidate will assist in planning, coordinating, and supporting clinical projects to ensure smooth operational delivery.The role involves administrative oversight, cross-functional collaboration, documentation management, and stakeholder communication. Candidates must demonstrate strong organizational skills, attention to detail, and the ability to manage multiple responsibilities in a dynamic environment.Key Features of the Role:• Exposure to global clinical research projects• Involvement in CTMS and eTMF systems• Hands-on project coordination experience• Opportunity to work within a leading CRO environment• Career progression in clinical project management• Participation in strategic planning discussionsResponsibilities• Support the development and execution of project plans• Coordinate project activities including meeting scheduling and documentation• Prepare agendas, record minutes, and maintain action trackers• Collaborate with cross-functional teams to ensure smooth communication• Contribute to project documentation and reporting for stakeholders• Provide guidance to junior associates when required• Maintain transparency and integrity in project support processes• Participate in project planning and decision-making discussions• Stay updated on industry trends and best practicesRequired QualificationsCandidates should demonstrate foundational project management knowledge and clinical operations exposure. Familiarity with CTMS and eTMF systems is essential. Strong organizational discipline and communication skills are critical to succeed in this role.Educational Requirements:• Bachelor’s or Master’s degree in Allied Health Sciences or Life Sciences disciplineExperience and Skills:• 1 to 3 years of experience in Project Management and Clinical Operations• Working knowledge of CTMS and eTMF systems• Excellent organizational and multitasking abilities• Strong written and verbal communication skills (Fluency in English required)• Detail-oriented mindset with problem-solving capabilities• Ability to manage deadlines in fast-paced environments• Collaborative team player with professional conductSalary InsightsCompensation is competitive and aligned with global CRO standards. Salary varies based on experience, expertise, and internal banding. In addition to base pay, ICON offers comprehensive benefits focused on employee well-being and work-life balance.Company OverviewICON plc is a world-leading clinical research organization specializing in healthcare intelligence and clinical development solutions. The company partners with pharmaceutical, biotechnology, and medical device organizations to accelerate innovation and improve patient outcomes.ICON is known for its inclusive work culture, strong performance-driven environment, and structured career development opportunities. Employees benefit from global exposure, collaborative teamwork, and access to industry-leading clinical technologies.FAQsIs CTMS and eTMF knowledge mandatory?Yes, working knowledge of CTMS and eTMF systems is required.What level of experience is needed?Candidates must have 1 to 3 years of experience in Project Management and Clinical Operations.Is this role client-facing?The role involves stakeholder coordination and cross-functional collaboration but primarily supports internal project teams.What growth opportunities are available?Career progression may include Senior Project Associate, Project Specialist, Clinical Project Coordinator, or Project Manager roles.Does ICON offer additional benefits?Yes, including health insurance, retirement planning, employee assistance programs, and flexible benefits.Application Tips• Highlight CTMS and eTMF system experience clearly on your resume• Showcase examples of project coordination and documentation management• Demonstrate strong communication and multitasking skills• Prepare to discuss your role in previous clinical projects• Emphasize ability to work within global cross-functional teams

Why This Role MattersThe Investigator Grants Specialist plays a critical role in ensuring the financial accuracy, transparency, and efficiency of clinical trial operations. In clinical research, timely and accurate investigator payments are essential for maintaining strong site relationships, ensuring compliance with contractual agreements, and supporting uninterrupted study progress. This role directly contributes to operational excellence by managing site budgets, processing investigator payments, and supporting grant development activities.By ensuring payments are aligned with subject visits, contractual terms, and study timelines, the Investigator Grants Specialist helps safeguard the integrity of clinical trials. The position also supports financial planning and budget development using industry-standard systems, ensuring fair market value compliance and regulatory alignment. Ultimately, this role strengthens partnerships between sponsors, research sites, and internal teams while contributing to the successful execution of clinical programs.Job DescriptionThe Investigator Grants Specialist is responsible for managing investigator payment processes and developing investigator grants using standardized systems such as Grant Plan and CTMS platforms. The role works closely with Project Management and Clinical Operations teams to ensure accurate site budget templates, subject visit tracking (SVT) setup, and timely processing of quarterly site payments.All activities are performed in compliance with company SOPs, client guidelines, and regulatory standards. The specialist ensures high-quality financial data management, timely escalation of issues, and strong communication across cross-functional teams. The role requires strong analytical capabilities, attention to detail, and the ability to manage multiple studies simultaneously.Key Features of the Role:• Management of investigator payments aligned with subject visit data.• Development and maintenance of investigator grants using industry-standard tools.• Close collaboration with Clinical Operations and Project Management teams.• Exposure to complex, multi-country clinical projects.• Involvement in budget modeling and fair market value assessment.• Responsibility for maintaining compliance with financial and regulatory requirements.• Participation in process improvement and SOP development initiatives.Responsibilities• Review, update, and track all investigator payments accurately within CTMS.• Ensure payments are processed in accordance with investigator contracts and agreed schedules.• Escalate payment discrepancies or delays to appropriate stakeholders.• Coordinate with Project Managers to resolve payment-related queries efficiently.• Review visit data in CTMS to ensure accurate subject visit tracking before payment release.• Prepare investigator payment reports for study meetings and internal reviews.• Maintain accurate setup and management of Subject Visit Tracking (SVT) templates.• Create site-specific SVTs based on Clinical Trial Research Agreements (CTRAs).• Ensure master and site-specific templates are built accurately within required timelines.• Develop investigator grants using Grant Plan or equivalent systems.• Review study protocols to prepare accurate and complete budget models.• Provide initial budget estimates for sponsors and support complex project assignments.• Apply industry-standard cost benchmarks and fair market value principles.• Coordinate with vendors for system access and technical support.• Track finalized budgets and maintain organized documentation for audits.• Participate in departmental meetings and contribute to process enhancement initiatives.• Maintain professional communication with sponsors, sites, and external stakeholders.Required Qualifications• Strong understanding of clinical trial payment processes.• Knowledge of CTMS platforms such as Veeva.• Experience in investigator grant development and budget preparation.• High level of attention to detail and organizational skills.• Strong analytical and problem-solving capabilities.• Ability to manage multiple tasks and meet strict deadlines.• Excellent written and verbal communication skills.Educational Requirements:• Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, or a related field is mandatory.• Advanced certifications in clinical research or finance are an added advantage.Experience and Skills:• 12–36 months of experience in a Clinical Research Organization (CRO), pharmaceutical, or healthcare environment.• Experience working in investigator payment processing.• Hands-on experience with CTMS and Grant Plan systems.• Strong proficiency in MS Excel and PowerPoint.• Understanding of Subject Visit Tracking and contract-based payment models.• Strong interpersonal and relationship-building skills.• Ability to work independently while collaborating within cross-functional teams.Salary InsightsThe salary for an Investigator Grants Specialist varies depending on experience, technical expertise, and project complexity. Candidates with hands-on CTMS and grant development experience typically command competitive compensation within the clinical research industry. Additional benefits may include performance-based incentives, flexible working arrangements, health benefits, paid parental leave, wellness programs, and professional development opportunities.Company OverviewNovotech is a global full-service Clinical Contract Research Organization (CRO) headquartered in Sydney, Australia. With offices across Asia-Pacific, North America, and Europe, the organization supports clinical development services across all phases and therapeutic areas. Novotech provides feasibility assessments, regulatory submissions, safety solutions, statistical analysis, medical monitoring, and project management services.The company maintains internationally recognized certifications including ISO 9001 for Quality Management and ISO 27001 for Information Security Management Systems. Novotech is committed to fostering an inclusive workplace, promoting diversity, and maintaining high professional standards across global operations.FAQs1. Is prior CRO experience mandatory?Yes, prior experience in a CRO, pharmaceutical, or healthcare setting is preferred.2. Is experience in CTMS essential?Yes, practical experience in CTMS systems such as Veeva is important for managing payments and tracking subject visits.3. Will the role involve handling complex budgets?Yes, candidates may be assigned to complex projects requiring advanced budget modeling and fair market value assessment.4. Does this role involve cross-functional collaboration?Yes, the position requires regular interaction with Project Managers, Clinical Operations teams, sponsors, and research sites.Application Tips• Highlight your CTMS and investigator payment experience clearly in your resume.• Emphasize any grant development or budget modeling exposure.• Showcase proficiency in MS Excel, especially financial tracking and reporting.• Demonstrate examples of managing multiple studies or tight deadlines.• Mention experience handling sponsor or site communication professionally.

Why This Role MattersThe Specialist I, Global Clinical Solutions role at AstraZeneca plays a critical part in ensuring clinical trials run efficiently, accurately, and in compliance with global standards. Behind every successful clinical study is a strong foundation of clean data, reliable systems, and precise clinical coding. This position safeguards that foundation.By supporting study delivery systems, maintaining coding accuracy, and providing first-line user support, you directly contribute to faster decision-making and smoother trial execution. The impact of this role extends beyond data—it helps accelerate the development of life-changing medicines for patients worldwide.Job DescriptionThe Specialist, Global Clinical Solutions will support global study teams by maintaining key clinical systems, ensuring data integrity, performing clinical coding activities, and resolving system-related queries. The role combines technical expertise, operational coordination, and user support to ensure global trials operate seamlessly.The candidate will collaborate across Clinical Development, Data Management, and Operations teams while contributing to process improvements and system integration initiatives.Key Features of the Role:• Global clinical trial exposure• Hands-on clinical coding and system stewardship• Cross-functional collaboration with study teams• First-line system and user support responsibilities• Hybrid work model (minimum three days per week in office)• Opportunity to contribute to non-drug project proposalsResponsibilities• Maintain systems related to Financial Disclosure, Drug Return and Destruction, Pairs Investigator Database, Investigator Safety Letter Distribution, and Clinical Trial Registration• Provide first-line user support for study delivery systems and resolve issues promptly• Monitor and maintain data integrity within Study Delivery (SD) systems• Process financial charges associated with study delivery support activities• Perform accurate clinical coding or review CRO-coded data (medical history, surgical history, adverse events, drugs) using approved coding dictionaries• Raise, track, and resolve coding-related queries according to global and local study processes• Monitor and respond to coding-related GDMRs and escalate to the GCDMT when required• Contribute to development of cases prioritizing non-drug project proposals• Share knowledge, maintain communication tools, and support global system integration• Ensure compliance with Safety, Health, and Environment (SHE) standardsEducational Requirements:• Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Biotechnology, or a related fieldEssential Skills and Experience:• Experience maintaining clinical study delivery systems• Strong understanding of clinical coding practices and dictionaries (e.g., MedDRA, WHO Drug)• Hands-on experience coding clinical study data• Knowledge of global and local study processes and timelines• Experience in first-line user support and data integrity monitoring• Familiarity with financial processing related to study support activities• Strong attention to detail and analytical skills• Effective communication and collaboration abilitiesDesirable Skills and Experience:• Experience supporting non-drug project proposal prioritization• Exposure to global system integration initiatives• Ability to contribute to continuous improvement strategies• Leadership mindset with collaborative approach• Commitment to quality, compliance, and innovationImportant Date• Closing Date: 03-Apr-2026Company OverviewAstraZeneca is a global, science-led biopharmaceutical company focused on the discovery, development, and commercialization of prescription medicines. The organization emphasizes innovation, digital transformation, and collaborative science to accelerate drug development and improve patient outcomes worldwide.With strong investments in data science, AI capabilities, and global collaboration, AstraZeneca fosters a culture of inclusion, scientific curiosity, and operational excellence.Work ModelThe role follows a hybrid working model with an average expectation of a minimum of three days per week in the office, balancing collaboration with individual flexibility.FAQs1. What type of role is this?It is a global clinical operations and systems support role focused on clinical coding and study delivery systems.2. Is clinical coding experience mandatory?Yes, hands-on coding or review experience of clinical study data is essential.3. Where is the job location?The position is based in Bangalore, India.4. What is the last date to apply?The closing date is 03-Apr-2026.5. Does the role involve cross-functional collaboration?Yes, the role requires working closely with Clinical Development, Data Management, and Operations teams globally.Application Tips• Highlight experience in clinical coding and study systems• Mention familiarity with coding dictionaries such as MedDRA and WHO Drug• Demonstrate experience in resolving system queries and supporting users• Showcase cross-functional collaboration examples• Apply early to ensure timely consideration

Why This Role MattersClinical trials are the backbone of medical advancement, ensuring that new treatments and therapies are safe, effective, and compliant with global regulatory standards. Behind every successful clinical study is a well-coordinated operations team that manages documentation, timelines, compliance, and communication across stakeholders.As a Clinical Trial Associate at ICON plc, you will play a critical support role in maintaining trial integrity, ensuring regulatory compliance, and facilitating collaboration across cross-functional teams. Your work directly contributes to the development of innovative medicines and therapies that impact patients worldwide.Job DescriptionICON plc is seeking a Clinical Trial Associate (Clinical Trial Administrator) to join its Bangalore-based team. In this role, you will assist in coordinating and administering clinical trials while ensuring adherence to study protocols, regulatory guidelines, and company standards.You will be responsible for managing trial documentation, supporting regulatory submissions, tracking milestones, and collaborating with project teams to ensure smooth and efficient trial execution. This role requires attention to detail, strong organizational skills, and the ability to work effectively in a fast-paced research environment.Key Features of the Role• Office-based role in Bangalore• Exposure to global clinical trial operations• Cross-functional collaboration with research teams• Competitive salary and benefits• Structured professional development• Opportunity to contribute to innovative treatment development• Inclusive and performance-driven work cultureResponsibilities• Assist in coordination and administration of clinical trials• Ensure compliance with study protocols and regulatory requirements• Maintain and organize clinical trial master files and essential documents• Support preparation of informed consent forms, case report forms, and study materials• Track clinical trial milestones and performance metrics• Facilitate communication between cross-functional teams• Assist in regulatory submissions and documentation updates• Maintain accurate records in accordance with GCP guidelinesRequired Qualifications• Bachelor’s degree in a scientific or healthcare-related field• Understanding of clinical trial processes and regulatory frameworks• Strong organizational and documentation skills• Ability to manage multiple tasks efficientlyEducational Requirements• Degree in Life Sciences, Pharmacy, Biotechnology, Nursing, or related healthcare discipline• Academic knowledge of clinical research methodology and regulatory requirementsExperience and Skills• Prior experience in clinical research (preferred)• Strong interest in clinical trial operations• Knowledge of ICH-GCP guidelines and regulatory compliance• Excellent written and verbal communication skills• High attention to detail and accuracy• Ability to collaborate effectively in cross-functional environments• Proficiency in Microsoft Office applications• Ability to work under deadlines in a structured corporate settingSalary InsightsICON plc offers competitive compensation aligned with industry standards in India. In addition to salary, employees may receive:• Annual leave entitlements• Health insurance coverage• Retirement planning benefits• Life assurance• Access to Global Employee Assistance Programme (LifeWorks)• Flexible country-specific benefits such as childcare vouchers, gym membership discounts, travel subsidies, and wellness programsCompensation and benefits may vary based on experience and company policy.Company OverviewICON plc is a world-leading healthcare intelligence and clinical research organization providing development and commercialization services to pharmaceutical, biotechnology, and medical device companies globally.The organization is committed to innovation, operational excellence, and fostering a diverse and inclusive workplace. With a strong global footprint, ICON plays a key role in supporting clinical trials that bring new therapies to patients worldwide.FAQsQ: Is prior clinical trial experience mandatory?Prior experience is preferred but strong interest and foundational knowledge in clinical research may be considered.Q: Is this role office-based?Yes, this is an office-based role in Bangalore.Q: What qualifications are required?A Bachelor’s degree in a scientific or healthcare-related field is required.Q: Does ICON provide employee benefits?Yes, ICON offers competitive salary and comprehensive benefits tailored to country-specific policies.Application Tips• Highlight any clinical research or regulatory experience• Mention familiarity with ICH-GCP guidelines• Emphasize documentation and organizational skills• Demonstrate ability to manage multiple tasks and deadlines• Showcase communication and teamwork capabilities

Roles & Responsibilities• Gain familiarity with Advarra’s Clinical Trial Management Software (CTMS), Institutional Review Board (IRB) systems, and CIRBI platform• Support Client Services teams in translation management, safety reporting, and ongoing reviews (site termination & IRB submissions)• Document issues, manage customer communications, and ensure smooth study start-up processes• Monitor and resolve customer escalations in a timely manner• Track and complete assigned tasks using internal case management software• Meet daily/weekly productivity and quality metrics in coordination with reporting manager• Participate in team meetings and provide insights on customer cases and study protocols• Maintain accurate documentation aligned with GCP and regulatory standardsQualification• Bachelor’s degree in Life Sciences, Pharmacy, Clinical Research, or related fieldExperience• 0–1 year of internship or relevant experience in:– Clinical trial coordination– Study Start-Up / Regulatory Affairs– IRB submissions– Clinical data management– Records managementSkills• Knowledge of clinical research methodology and GCP guidelines• Understanding of study start-up and regulatory processes• Proficiency in MS Office and business software tools• Strong organizational and administrative skills• Excellent written and verbal communication skills• Strong problem-solving abilities and customer service orientation• Ability to work independently and collaboratively in a team environment• High attention to detail and strong time management skillsAbout the CompanyAdvarra is a global leader in clinical research solutions, providing ethical review services, regulatory expertise, and innovative technology platforms that connect patients, sponsors, CROs, and research sites to accelerate high-quality clinical trials worldwide.

Roles & Responsibilities• Act as Lead Data Manager for one or more projects, owning end-to-end data management activities or supporting the Lead DM as required• Lead DM activities for individual, limited volume/complexity studies with guidance from senior team members• Apply project protocol requirements to daily DM tasks and guide team members on correct protocol application• Serve as liaison to Project Lead and/or client, and communicate DM status, risks, and updates to management• Develop and maintain data management documentation files and perform independent reviews of DM deliverables as per CDM guidelines• Develop and deliver study-specific training for DM project staff and support team capability building• Produce regular project status reports for management, Project Lead, and/or clients, and monitor study metrics• Support forecasting of hours, identify resource needs, and flag potential out-of-scope activities, assisting with contract modification processes• Mentor junior staff on study-related DM tasks and ensure quality delivery standards• Assist with administrative and financial management of allocated projects while delivering DM activities independently with strong quality focus• Support business development activities including bid preparation and participation in bid defense meetings where requiredQualification• Bachelor’s degree or equivalent relevant academic/vocational qualificationExperience• 4+ years of experience in a Clinical Data Manager role• Strong hands-on working experience in Veeva EDC required• End-to-end data management experience across Set-Up, Conduct, and Close-Out• Oncology trial experience preferredSkills• Lead data management execution and client/stakeholder coordination• Strong protocol understanding and ability to translate protocol into DM workflows• CDM documentation management and independent deliverable review• Study metrics monitoring, status reporting, and operational tracking• Resource forecasting, scope management, and support for contract modification activities• Team mentoring, training delivery, and study team direction• Strong attention to detail, analytical/problem-solving skills, and structured execution• Excellent written and verbal communication with strong English grammar• Ability to work with minimal supervision while maintaining high confidentiality of clinical and proprietary data• Strong customer focus, interpersonal skills, flexibility, and adaptabilityAbout The CompanyThermo Fisher Scientific, through its PPD clinical research services portfolio, supports global clinical trials and data management delivery for leading pharmaceutical and biotech clients. With a mission to make the world healthier, cleaner, and safer, the organization offers collaborative teams, development opportunities, and technology-enabled clinical research services at scale across international studies.

Role & Responsibilities• Provide Pre-QC of documents prior to upload and indexing in the eTMF system.• Support maintenance and management of TMF records for assigned clinical trials.• Ensure timely and accurate uploading, naming, and indexing of clinical documentation.• Collaborate with study teams to resolve document queries and discrepancies.• Maintain compliance with the DIA Reference Model for TMFs and ICH GCP guidelines.• Uphold established standards for documentation accuracy, completeness, and traceability.• Assist with TMF filing and document retrieval as required.• Support TMF readiness for regulatory audits and inspections.• Manage study-specific TMF index and document records in the eTMF system (e.g., Veeva Vault).• Maintain and update the Electronic Document List (EDL) for assigned studies.• Provide operational support to clinical trial teams for TMF index management and inspection preparedness.• Conduct periodic TMF checks and share identified queries and gaps with the TMF Manager.• Ensure TMF records are compliant with DIA Reference Model, ICH GCP, and regulatory requirements.• Support timely and accurate filing of clinical research documents.• Collaborate cross-functionally to ensure consistent documentation processes.Qualification• Bachelor’s degree in life sciences, healthcare, pharmacy, or related field.Experience• Minimum of 1 year of relevant experience in clinical operations and/or clinical document management (eTMF preferred).• Working knowledge of clinical research documents.• Knowledge of ICH GCP and regulatory guidance.Vacancies• 30 VacanciesSkills• Skilled in verbal and written communication.• Proficient in Microsoft Office suite (Word, Excel, etc.).• Experience with Veeva Vault or similar eTMF platforms.• Knowledge of the DIA Reference Model for TMFs.• Experience in a fast-paced, cross-functional environment.• Familiarity with eCTD binders and CSR.About The CompanyVARITE is a global staffing and IT consulting company providing technical consulting and team augmentation services to Fortune 500 companies in the USA, UK, Canada, and India. The company works across multiple verticals such as Networking, Cloud Infrastructure, Clinical Diagnostics, Gaming, and Financial Services. VARITE is committed to creating an inclusive work environment and is an equal opportunity employer.

Role & Responsibilities• Manage FSP staff, including interviewing, job description preparation, professional development, goal setting, performance management, coaching, mentoring, employee counseling, and separations.• Approve courses of action on salary administration, hiring, corrective action, and terminations.• Review and approve time records, expense reports, requests for leave, and overtime.• Provide support, oversight, and coaching to the portfolio team to ensure tasks are completed accurately, on time, and within budget.• Manage resourcing (allocations) for all assigned staff, including global resourcing reporting and strategizing with senior management.• Ensure staff compliance with documented procedures.• Assist with implementation of operational activities with a focus on quality to better support the study manager.• Participate in the development and implementation of processes, procedures, and training for the data management function.Qualification• Bachelor's degree or equivalent and relevant formal academic/vocational qualification.Experience• 12+ years of relevant experience.• 5+ years of leadership responsibility.• Strong working experience in operating the FSP business model.Vacancies• 1 VacancySkills• Ability to apply knowledge and skills in an organized fashion while adhering to regulatory guidelines, SOPs, and client expectations.• Strong attention to detail and skill with numbers.• Excellent written and verbal communication skills with good command of English.• Strong analytical and problem-solving skills.• Ability to maintain confidentiality with clinical and proprietary data.• Good interpersonal skills.• Ability to act as a study expert for DM processes.• Ability to manage and motivate others, supervise and delegate tasks effectively.• Ability to set and meet timelines or recognize and schedule changes in response to project demands.About The CompanyThermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $44 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer. With over 90,000 colleagues, they provide innovative technologies and services through leading brands like Thermo Scientific, Applied Biosystems, Invitrogen, and more. Thermo Fisher is committed to research, development, and making a significant impact on healthcare.

Roles & Responsibilities• Perform site monitoring visits (selection, initiation, monitoring, and close-out visits) in accordance with GCP and ICH guidelines.• Work with sites to drive and track subject recruitment plans to meet project needs and enhance predictability.• Administer protocol and related study training to assigned sites and establish regular communication to manage project expectations and issues.• Evaluate the quality and integrity of study site practices and adherence to regulations, escalating quality issues as necessary.• Track the progress of assigned studies, including regulatory submissions, recruitment, CRF completion, and data query resolution.• Ensure site documents are available for filing in the Trial Master File (TMF) and ensure Investigator's Site File (ISF) is maintained according to GCP/ICH and local requirements.• Create and maintain documentation regarding site management and monitoring visit findings, submitting regular reports and follow-up letters.• Collaborate with study team members for project execution support as needed.• If applicable, support development of site-specific subject recruitment plans and manage site financials per clinical trial agreements.Qualification• Relevant qualification in life sciences, clinical research, or related fields.Experience• 3+ years of relevant experience in Clinical Research.Vacancies• Multiple positions available in Bangalore, Mumbai, Ahmedabad, and Delhi.Skills• Strong knowledge of GCP, ICH, and regulatory guidelines.• Excellent communication and interpersonal skills.• Ability to manage site monitoring, recruitment, and data queries effectively.• Experience with Trial Master File (TMF) and Investigator's Site File (ISF).• Strong organizational skills and ability to track study progress.About the CompanyIQVIA India is a global leader in healthcare data and analytics, providing solutions to help clients in the pharmaceutical, biotechnology, and healthcare industries. IQVIA’s mission is to enable healthcare organizations to navigate complex data, deliver insights, and improve patient outcomes through advanced technology and clinical expertise.

Roles & Responsibilities:• Maintain and manage electronic Trial Master File (eTMF) documentation• Ensure completeness and accuracy of essential clinical trial documents• Support clinical operations teams with document tracking, filing, and reconciliation• Perform quality checks on trial documentation• Ensure compliance with ICH-GCP guidelines and regulatory requirements• Maintain documentation logs and support audits/inspections• Coordinate with cross-functional teams to ensure inspection readinessQualification:• Bachelor’s degree in Life Sciences / Pharmacy / Healthcare / Related fieldExperience:• 1 – 5 yearsSkills:• Experience in clinical operations or eTMF document management• Strong understanding of TMF structure and clinical research documentation• Knowledge of ICH-GCP and regulatory standards• Proficiency in MS Office (Word, Excel, etc.)• Good written and verbal communication skills• Attention to detail and compliance-focused mindsetPreferred Background:• Experience as Clinical Research Coordinator (CRC)• TMF Specialist / Clinical Document Management roles• Prior experience in clinical research documentationAbout the Organization:VARITE Inc is a global staffing and consulting firm that partners with leading pharmaceutical, healthcare, and technology companies. The organization focuses on delivering talent solutions in clinical research, regulatory operations, and business services, offering strong career growth opportunities in the life sciences sector.

Roles & Responsibilities• Own assigned sites from initiation to close-out• Conduct SIVs, routine monitoring visits, and COVs per plan• Oversee patient recruitment, eligibility verification, informed consent process, and follow-up compliance• Design CRFs, implement automated quality checks to reduce manual processing time• Ensure strict adherence to protocols, GCP, ICH, ISO 14155• Proactively identify risks, deviations, and non-compliance, and drive resolution• Train and support site staff and junior coordinators on protocol procedures, EDC usage, and GCP requirements• Collaborate with sponsors, CROs, investigators, and data management teams for study oversight and data reconciliation• Perform rigorous SDV/SDR to ensure accuracy, completeness, and timeliness• Own site-level query management, follow-ups, and closures• Ensure source → EDC traceability and contemporaneous documentation• Support database lock readiness through disciplined site cleanup• Document deviations, non-compliances, and AEs/SAEs accurately and on time• Support CAPA implementation at the site level and verify effectiveness• Solve problems at the site and escalate only when necessary• Ensure sites are inspection-ready at all times• Support internal audits, sponsor audits, and regulatory inspections• Maintain complete, accurate TMF documentation for assigned sites• Assist in regulatory submissions, IEC/IRB correspondence, SAE reporting, and TMF maintenance• Work closely with Clinical Operations & Data Quality Manager on risks, timelines, and site performance• Partner with investigators and site staff to improve compliance and data quality• Provide clear, timely monitoring reports and follow-through on actionsQualification• 3-4 years of experience as a Clinical Research Associate• Proven hands-on experience in site monitoring and SDV• Strong understanding of GCP, ICH, ISO 14155• Experience with EDC systems and query management• Comfortable independently managing multiple sitesExperience• Medical device trial experience• Exposure to audits or regulatory inspections• Experience supporting database lock activities• Utilization of Python and SPSS for data validation, statistical reporting, and workflow automation• Support investigators in abstract development, scientific presentations, and statistical analysis reporting• Contribute to protocol development, manuscript drafting, and journal submission processesSkills• Strong execution focus and attention to detail• Low tolerance for sloppy documentation or shortcuts• Enjoys solving real problems in real clinical settingsAbout the CompanyRemidio is an innovative healthcare company focused on delivering high-quality solutions in clinical research. The role offers an opportunity to work with a dynamic team, managing clinical trials with a focus on data quality, compliance, and strategic execution.

Roles & Responsibilities• Coordinate and deliver Global Clinical Solutions (GCS) services ensuring lifecycle management and business continuity for projects, services, and technology• Provide expert user support including conducting system/process/tool training and facilitating knowledge sharing across teams• Establish guidelines, protocols, and communication frameworks with cross-functional collaborators• Analyze processes, tools, and systems to identify opportunities for efficiency improvement and risk reduction• Lead and manage continuous improvement projects using lean principles including planning, prioritization, execution, and delivery tracking• Support implementation of organizational and functional changes to enhance performance and operational efficiency• Monitor program performance, evaluate effectiveness, and recommend corrective actions when required• Train and mentor teams in continuous improvement methodologies and change adoption• Develop and maintain knowledge management frameworks to capture and reuse organizational learning• Act as a subject matter expert in one or more GCS domains and guide protocol development and standards• Contribute to business continuity planning and service optimization across global clinical operationsQualification• Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Clinical Research, Business Administration, or related disciplineExperience• Experience in clinical development, clinical operations, or clinical technology platforms• Hands-on experience in lifecycle management, service delivery, and business continuity planning• Experience leading continuous improvement or transformation projects• Exposure to regulated environments and quality systems (GxP) preferredSkills• Strong knowledge of lean improvement methodologies (Lean / Six Sigma preferred)• Expertise in process improvement, risk management, and change implementation frameworks (e.g., Prosci/ADKAR preferred)• Ability to design and deliver training programs and user support initiatives• Strong stakeholder and collaborator management across global matrix environments• Experience developing performance dashboards, KPIs, and benefits tracking metrics• Knowledge of knowledge management tools and continuous improvement frameworks• Strong analytical, communication, and leadership skills with focus on scalable solutionsAbout the OrganizationAstraZeneca is a global, science-led biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines. By combining science, technology, and collaborative thinking, the organization accelerates clinical development and improves patient outcomes while fostering a culture of continuous learning and innovation.

Roles & Responsibilities• Design, execute, and optimize integrated marketing campaigns across the provider journey to meet business objectives• Orchestrate delivery of campaign plans aligned with overall marketing strategy• Manage campaign calendars, timelines, and annual marketing plans• Lead tactic sequencing, prioritization, and end-to-end project management• Guide content strategy and messaging across media, web, email, sales tools, events, and other channels• Manage audience marketing budgets including media, agencies, and creative partners• Analyze campaign performance data and report KPIs and insights to drive optimization• Manage third-party vendors and internal channel partners for campaign execution• Collaborate with Product Management and Product Marketing teams on goals, market sizing, and positioning• Lead recurring stakeholder meetings to ensure timely and accurate campaign execution• Partner cross-functionally with Sales, Medical Affairs, Science, and Operations teams• Apply journey-based marketing strategies to deliver the right message at the right time• Ensure consistent brand experience, voice, and visuals across all marketing channelsQualification• Bachelor’s degree in Science or related disciplineExperience• 10+ years of marketing experience within healthcare or pharmaceutical industry• Experience in biopharmaceutical or oncology segment preferredSkills• Strong expertise in multi-channel and omni-channel marketing strategies• Deep understanding of customer journey and audience targeting• Knowledge of account-based marketing (ABM)• Strong experience with marketing automation tools, especially Eloqua• Working knowledge of CRM databases• Understanding of digital marketing technologies and AI platforms• Strong communication, copywriting, and editing skills• Excellent project management, organization, and data analysis skills• Ability to work effectively in a highly matrixed, global environment• Open to working across time zonesAbout the OrganizationLabcorp is a global leader in life sciences and diagnostics, supporting healthcare decisions through advanced laboratory services and integrated clinical solutions. The organization is committed to innovation, inclusion, and delivering high-quality outcomes for patients, providers, and partners worldwide.

Roles & Responsibilities• Assist with overall safety trackers, applications, and tools implementation, support, configuration, and migration activities• Provide service to clients either as a support function to client project groups or as a standalone business• Ensure delivery of high-quality service to internal and external clients in a safe and cost-effective manner• Conduct project-specific configurations in safety applications/tools• Maintain and document trackers/applications/tools configuration based on requirements and updates• Evaluate proposed project ideas or software changes through technical impact analysis and estimated business value• Develop and document standard and ad hoc reports from safety trackers/applications/tools• Support and educate end users and sponsors as needed• Collaborate with training teams to develop safety application/tool-specific training modules• Document user requirements and ensure timely delivery in collaboration with technical partners• Provide guidance on use of standard safety trackers/tools, including advanced conditions and Standard MedDRA Queries (SMQ)• Conduct routine and ad hoc data extraction (e.g., PSURs, DSURs, 6-monthly listings)• Participate in data migration activities and related documentation• Support change management and user training for trackers/tools• Manage ticketing, issue resolution, and escalate issues as needed• Respond to mailbox queries and provide vendor management support• Train team members on technical and functional aspects of safety tools• Update departmental SOPs, working practices, and guidelines• Monitor tracker/tool failures and resolve issues promptly• Perform user acceptance testing and complete required documentation• Lead critical team projects and manage team workloadQualification• Degree in Life Sciences, IT, or Computing (relevant equivalent experience may be considered)Experience• Minimum 2 years in safety trackers/applications/tools operations support• Experience with validated document management systems and drug safety trackers (e.g., intake/SAE/ESR trackers, SharePoint, in-house tools)• Clinical background with clinical systems is preferredSkills• Strong technical and functional knowledge of PV systems• Good understanding of SQL and ticket support applications• Proficiency in Microsoft Office tools• Strong attention to detail and ability to handle multiple priorities• Good written and verbal communication skills• Ability to work collaboratively and provide peer supportAbout the CompanyFortrea is a global leader in clinical research and pharmacovigilance services, providing innovative solutions for drug safety, clinical trial operations, and regulatory compliance. With a presence in India and worldwide, Fortrea offers professionals exposure to advanced clinical technologies, validated systems, and global trial operations while fostering a collaborative and high-quality service-driven work culture.

Roles & Responsibilities:• Conduct preclinical laboratory experiments supporting late-stage BMS asset programs• Generate biomarker data to support patient selection strategies, dose & schedule optimization• Design and execute experiments for combination strategies, resistance mechanism studies, and differentiation from standard of care• Execute internal and collaborative translational projects, interfacing with Translational Medicine scientists and disease leaders• Maintain accurate experimental records and present findings to internal teams• Prepare non-clinical pharmacology study reports to support regulatory submissions• Handle in vivo studies in autoimmune, solid tumor, or heme-oncology models as requiredQualification:• Master’s degree (MSc, MS, MTech, or equivalent) in Life Sciences, Biotechnology, or related disciplineExperience:• Relevant experience in immunology, oncology, or hemato-oncology research• Industry experience in translational or preclinical research is preferredSkills:• Cell culture, primary cell isolation, transfection, single-cell cloning• Gene editing workflows: siRNA, CRISPR, TALEN, HDR• Gene expression analysis: qRT-PCR, RNA-Seq• Epigenetics techniques: ChIP, methylation analysis• Protein & immunoassays: ELISA, MSD, Luminex, CBA, TSA• Flow cytometry and cell phenotyping• Strong scientific writing, data analysis, and problem-solving skills• Ability to work with animal models and human-derived samples; GCLP/CLIA exposure is a plusBehavioral & Soft Skills:• Self-driven, detail-oriented, and quality-focused researcher• Comfortable in fast-paced, matrixed environments• Excellent multitasking, troubleshooting, and independent working abilities• Willingness to handle complex experiments and patient-derived samplesAbout the Organisation:Syngene International Ltd. is a leading contract research organization providing integrated, discovery-to-development solutions for global pharmaceutical and biotech companies. Its Translational Medicine division focuses on biomarker-driven, preclinical research to support late-stage drug development. The company fosters a collaborative, innovative environment that enables researchers to contribute to cutting-edge projects in oncology, immunology, and translational medicine.

Roles & Responsibilities• Perform end-to-end clinical data management activities for assigned studies• Review and evaluate clinical trial imaging and clinical data for accuracy and compliance• Collaborate with project teams to define study-specific edit checks• Run, review, and resolve data queries and discrepancies• Support study setup including database structure, specifications, and TF design• Coordinate receipt, integration, and processing of external and electronic clinical data• Maintain complete, accurate, and audit-ready study documentation• Track open data issues and ensure timely resolution• Ensure CDM activities comply with regulatory guidelines and internal SOPs• Participate in client meetings and cross-functional discussions• Continuously enhance technical and industry knowledge through trainingQualification• Bachelor’s degree in Life Sciences, Computer Science, or a related discipline• Equivalent clinical data management experience will be consideredExperience• Minimum 1 year of experience in Clinical Data Management (Pharma, Biotech, or CRO)Skills• Strong understanding of clinical trial terminology and CDM processes• Working knowledge of relational databases and data validation• SAS knowledge is desirable• Proficiency in MS Word, Excel, and Access• Strong analytical skills with high attention to detail• Excellent documentation, organizational, and communication skills• Ability to work independently and effectively in fast-paced team environmentsAbout the OrganisationClario is a global leader in clinical trial endpoint technology, delivering innovative imaging, cardiac safety, and digital endpoint solutions to support clinical trials worldwide. The company partners with leading pharmaceutical, biotech, and medical device organizations, offering professionals exposure to global studies, advanced technology platforms, and diverse therapeutic areas.

Role & Responsibilities• Perform end-to-end clinical data management deliverables for assigned studies• Review and evaluate clinical trial imaging data for accuracy and compliance• Collaborate with project teams to define study-specific edit checks• Run, review, and resolve data discrepancies and queries• Support study setup, including database structure, specifications, and TF design• Coordinate receipt and processing of external and electronic clinical data• Maintain complete and audit-ready study documentation• Track open data issues and ensure timely resolution• Ensure all CDM activities comply with regulatory guidelines and SOPs• Participate in client meetings and cross-functional discussions• Continuously upgrade technical and industry knowledge through trainingSkills• Strong attention to detail and analytical skills• Excellent documentation and organizational abilities• Effective communication and interpersonal skills• Ability to work independently and in fast-paced team environments• Working knowledge of relational databases and data validation• Proficiency in MS Word, Excel, and Access• SAS knowledge is desirable• Understanding of clinical trial terminologyQualifications• Bachelor’s degree in Life Sciences, Computer Science, or related discipline• Equivalent clinical data management experience will be consideredSalary & Benefits• Salary Range: ₹6,00,000 – ₹9,00,000 per annum (INR)• Provident Fund (PF)• Comprehensive Medical Insurance• Performance incentives• Remote & hybrid work flexibility• Modern office infrastructure• Employee engagement programs and learning opportunitiesAbout The Company• Clario is a global leader in clinical trial endpoint technology with over 50 years of expertise in supporting clinical trials.