Clinical Research Jobs in Hyderabad

Why This Role MattersIn clinical research, accurate and reliable data collection is essential for evaluating the safety and effectiveness of investigational treatments. Clinical trials generate large volumes of patient data that must be recorded, validated, and maintained according to strict regulatory standards. Electronic Data Capture (EDC) systems play a critical role in managing this data efficiently and ensuring that clinical trial information remains accurate, secure, and compliant with regulatory requirements.The EDC Coordinator plays an important role in supporting clinical research teams by managing electronic data entry workflows, monitoring data quality, and resolving discrepancies within clinical trial databases. By ensuring that study data is complete, accurate, and aligned with regulatory standards such as Good Clinical Practice (GCP) and FDA guidelines, the EDC Coordinator contributes directly to the integrity and reliability of clinical trial outcomes.This role is ideal for life sciences and healthcare professionals interested in clinical data management, clinical operations, and regulatory compliance within the clinical research industry.Job DescriptionThe EDC Coordinator is responsible for supporting clinical research teams in managing electronic data capture systems used during clinical trials. The role involves assisting site staff with data entry, validating study data, resolving data queries, and ensuring compliance with regulatory and sponsor requirements. Professionals in this role work closely with clinical research teams, sponsors, and IT departments to maintain the accuracy and integrity of clinical trial databases. They monitor discrepancies, perform data cleaning activities, and address technical issues related to EDC systems.The position requires strong attention to detail, analytical thinking, and the ability to work in a fast-paced clinical research environment while maintaining high standards of data accuracy and regulatory compliance.Key Features of the Role• Job Title: EDC Coordinator / Clinical Data Management Coordinator• Functional Area: Clinical Data Management• Industry: Clinical Research / Healthcare• Work Environment: Clinical research site or clinical operations team• Experience Level: Early-career clinical research professionalResponsibilities• Supporting clinical research site staff with accurate data entry into Electronic Data Capture systems.• Resolving data queries and performing validation checks to maintain data quality.• Ensuring data management processes comply with Good Clinical Practice (GCP), FDA, and sponsor-specific regulations.• Monitoring data discrepancies and performing data cleaning activities.• Collaborating with clinical research teams, sponsors, and IT teams to optimize data workflows.• Supporting data collection, reporting, and system security processes.• Identifying and troubleshooting issues within the EDC system and escalating technical problems when necessary.• Ensuring proper documentation of data management activities according to regulatory standards.• Maintaining data accuracy, integrity, and audit readiness throughout the clinical trial process.• Performing additional tasks assigned by management to support clinical research operations.Required QualificationsEducational Requirements• Bachelor’s Degree in Life Sciences• Bachelor’s Degree in Healthcare or Clinical Research-related field• Technical Degree in healthcare, laboratory sciences, or related disciplineExperience• 1–2 years of experience in clinical research, healthcare, laboratory, or data management environments.• Experience working with Electronic Data Capture (EDC) systems is an advantage.• Familiarity with clinical trial data collection and documentation processes.Skills and Competencies• Strong understanding of clinical trial data collection processes.• Knowledge of Good Clinical Practice (GCP) guidelines and regulatory standards.• Familiarity with research regulations such as IRB and FDA guidelines.• Excellent analytical and problem-solving skills.• High attention to detail and data accuracy.• Strong organizational and documentation skills.• Ability to work independently and collaboratively within a research team.• Good communication skills for interacting with clinical teams and sponsors.Salary InsightsThe salary for EDC Coordinators varies depending on experience level, organization type, and geographic location within the clinical research industry.Employees in this field may also receive additional benefits such as:• Exposure to clinical trial operations and clinical data systems• Opportunities for career advancement in clinical data management• Professional training in regulatory compliance and clinical research technologies• Opportunities to transition into roles such as Clinical Data Manager, Clinical Research Associate (CRA), or Data AnalystCompany OverviewOrganizations hiring EDC Coordinators are typically clinical research sites, hospitals, pharmaceutical companies, or Contract Research Organizations (CROs). These organizations conduct clinical trials to evaluate new treatments, medical devices, and therapies.EDC Coordinators support the data management infrastructure of clinical trials by ensuring that patient data collected during studies is accurate, secure, and compliant with regulatory requirements. Their work helps researchers, sponsors, and regulators make informed decisions about the safety and effectiveness of medical treatments.FAQs1. What does an EDC Coordinator do in clinical research?An EDC Coordinator manages electronic data capture systems used in clinical trials, ensuring accurate data entry, resolving queries, and maintaining data quality.2. What qualifications are required for this role?Most employers prefer candidates with a bachelor’s degree in life sciences, healthcare, or a related field along with some clinical research experience.3. Is knowledge of GCP important for this role?Yes, understanding Good Clinical Practice (GCP) guidelines is important because clinical trial data must comply with regulatory standards.4. What software do EDC Coordinators use?They typically work with Electronic Data Capture systems such as Medidata Rave, Oracle Clinical, or similar clinical trial data platforms.5. What career growth opportunities exist after this role?Professionals can progress to roles such as Clinical Data Manager, Senior Data Coordinator, Clinical Research Associate (CRA), or Clinical Data Analyst.Application Tips• Highlight experience with clinical data entry or clinical research documentation.• Mention knowledge of GCP, FDA regulations, or IRB guidelines.• Showcase analytical skills and attention to detail.• Include any experience with Electronic Data Capture (EDC) systems.• Emphasize teamwork and communication skills for working with clinical research teams.

Why This Role MattersClinical trial labeling is a critical compliance function that directly impacts patient safety, regulatory adherence, and supply chain integrity. Accurate labeling of Investigational Medicinal Products (IMPs) ensures proper identification, traceability, and compliance with country-specific Health Authority requirements.This role plays a vital operational and regulatory function by ensuring that labels are designed, reviewed, and executed in alignment with study protocols, packaging configurations, and GMP standards. Precision, regulatory awareness, and strong cross-functional coordination are essential to ensure inspection readiness and right-first-time (RFT) performance.Professionals in this position support smooth clinical trial execution while maintaining high standards of quality and compliance.Job DescriptionThe Clinical Trial Labeling Specialist is responsible for executing label design activities and reviewing related documentation in alignment with the labeling strategy defined by the Label Lead. The role ensures timely generation of compliant labels, maintenance of documentation repositories, and transparent status reporting throughout the labeling lifecycle.The position requires strong knowledge of GMP, study design alignment, and Health Authority requirements, along with effective stakeholder coordination.Key Features of the Role• End-to-end involvement in IMP label generation and documentation• Exposure to global Health Authority requirements• Compliance-driven role aligned with GMP and HSE standards• Cross-functional collaboration with Clinical Trial Supply and Supply Chain teams• Participation in inspections and quality audits• Opportunity to contribute to labeling process improvementsResponsibilities• Generate labels for Investigational Medicinal Products (IMP) as per study requirements• Create and manage randomization lists and schedules where applicable• Design labels based on strategic inputs and specific protocol requirements• Acknowledge and manage assigned tickets to ensure workflow continuity• Upload study-related forms, Study Label Templates (SLTs), and documentation into designated repositories accurately• Provide regular status updates to the Label Lead regarding progress and issues• Ensure label compliance with study design, pack design, analytical specifications, and country-specific Health Authority requirements• Maintain and update the Phrase Library containing validated country-specific regulatory requirements and translations• Perform and document GMP line unit checks (LU1b) if certified and required as per SOP• Report quality events, deviations, or non-Right First Time (RFT) cases to the Team Head or Deputy• Coordinate with internal stakeholders such as Clinical Trial Supply Managers and Supply Chain Managers• Collaborate with external label service providers for specialized labeling requirements• Support inspection readiness by explaining labeling processes during internal and external audits• Participate actively in projects, forums, and process improvement initiatives• Ensure execution of assigned tasks according to agreed quality, quantity, and timelines• Adhere strictly to established procedures, GMP standards, and organizational valuesRequired Qualifications• Strong understanding of GMP and Health Authority requirements• Ability to interpret study design and packaging specifications• Basic project management and planning skills• Strong organizational and documentation capabilities• Ability to work in cross-functional and interdisciplinary teams• Problem-solving and analytical thinking skillsEducational Requirements• Degree in Science, Engineering, or equivalent qualification• Apprenticeship or formal education in logistical, technical, or related business areas is advantageousExperience and Skills• Minimum 2 years of practical experience in the chemical or pharmaceutical industry, or more than 3 years of experience in a related field• Working knowledge of HSE and GMP standards• Experience in labeling operations or clinical supply processes preferred• Basic understanding of randomization schedules and clinical trial documentation• Good communication and negotiation skills• Presentation and stakeholder management capabilities• Fundamental leadership abilities• Strong planning, prioritization, and time management skillsSalary Insights• Compensation depends on experience level, certification, and organizational scope• Professionals with GMP-certified labeling experience and inspection exposure may fall within mid-level pharmaceutical compensation brackets• Additional responsibilities such as GMP line checks may positively influence salary positioningCompany OverviewNovartis is a global healthcare company focused on innovative medicines that improve and extend people’s lives. With a strong commitment to quality, compliance, and patient safety, Novartis operates in numerous countries and maintains rigorous standards in clinical research, manufacturing, and regulatory processes.The organization emphasizes adherence to GMP standards, operational excellence, and strong ethical values, providing professionals with opportunities to grow within a structured and quality-focused environment.FAQs• Is GMP knowledge mandatory? Yes, understanding of GMP standards and compliance processes is essential.• Does this role involve audits? Yes, participation in internal and external inspections may be required.• Is randomization schedule experience necessary? It is beneficial but not mandatory if other labeling experience is strong.• Does this role require stakeholder coordination? Yes, regular interaction with internal and external partners is part of the role.Application Tips• Highlight hands-on labeling experience in clinical trials or pharmaceutical manufacturing• Emphasize GMP compliance exposure and inspection readiness experience• Mention involvement in documentation control and repository management• Demonstrate coordination with cross-functional teams• Provide examples of maintaining Right First Time (RFT) quality standards

Why This Role MattersThe Lead Central Monitoring Manager plays a strategic leadership role in strengthening Risk-Based Quality Management (RBQM) within Global Clinical Operations at Novartis. As clinical trials grow more complex and data-driven, centralized monitoring has become essential to ensure proactive risk detection, patient safety, and data integrity.This role drives excellence in clinical trial oversight by establishing and delivering a modern, technology-enabled Central Monitoring (CM) capability. By aligning centralized and site monitoring strategies with program-level and study-level risks, the Lead CM ensures that clinical data surveillance is timely, accurate, and aligned with global regulatory expectations.Through strong leadership, analytics-driven insights, and cross-functional collaboration, this position directly contributes to delivering high-quality clinical data that supports regulatory submissions and patient-centric innovation worldwide.Job DescriptionThe Lead Central Monitoring Manager supports the Central Monitoring Head in building and advancing a state-of-the-art centralized monitoring function within Global Clinical Operations (GCO). The role is responsible for managing a team of Central Monitors and overseeing a portfolio of programs and trials within a designated Development Unit (DU).This position ensures that centralized monitoring strategies are aligned with the Integrated Quality Risk Management Plan (IQRMP) and tailored to study-specific risks. The Lead CM plays a key role in embedding risk-based principles throughout the clinical trial lifecycle, from protocol development through study close-out.The role combines leadership, governance, analytics oversight, and operational execution to ensure robust detection, assessment, escalation, and mitigation of clinical trial risks.Key Features of the Role• Leadership of 5–8 Central Monitors within Global Clinical Operations• Oversight of centralized monitoring strategy across assigned Development Unit• Strategic involvement in protocol development and risk identification• Ownership of Trial Monitoring Plans covering standard and trial-specific risks• Integration of data analytics, dashboards, and visualization tools for risk detection• Collaboration with Risk Surveillance Leads (RSLs) and Clinical Trial Teams (CTTs)• Contribution to Risk-Based Quality Management (RBQM) and Quality by Design (QbD) initiatives• Governance, audit readiness, and inspection support responsibilities• Opportunity to drive innovation in analytics-driven clinical oversight• Global stakeholder engagement across cross-functional clinical teamsResponsibilities• Manage and mentor a team of Central Monitors, ensuring high performance and professional development• Develop, refine, and implement centralized and site monitoring strategies aligned with IQRMP• Contribute to protocol development by supporting risk identification, assessment, and oversight planning• Design and optimize Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs)• Oversee configuration and utilization of Central Monitoring platforms at trial level• Monitor aggregated clinical data to detect trends, signals, and potential risks• Ensure translation of data outputs into actionable insights for Clinical Trial Teams• Act as primary escalation point for complex risk signals and critical study issues• Ensure appropriate trial data surveillance to maintain quality and integrity of clinical data• Lead harmonization of centralized monitoring practices across assigned programs• Participate in Critical-to-Quality (CtQ) risk review meetings• Collaborate with RSLs, Study Leaders, Data Managers, Clinical Scientific Leaders, and Data Analysts• Ensure comprehensive documentation of monitoring activities and risk resolutions• Maintain audit readiness and support regulatory inspections• Monitor effectiveness of CM strategies and implement continuous improvements• Contribute to IQRMP development using lessons learned to enhance mitigation strategies• Drive innovation in analytics, visualization tools, and data-driven monitoring techniques• Ensure timely and quality execution of CTT risk review meetings within assigned DUQualifications• University degree in Life Sciences, Business, or Operations• Advanced degree preferred• Fluent in written and spoken English• Minimum 7 years of pharmaceutical industry experience in Pharma or CRO environment• Minimum 5 years of comprehensive monitoring experience (central or site-based)• Minimum 3 years of people management or team leadership experience• Hands-on experience with KRIs, QTLs, centralized monitoring platforms, and RBQM frameworks strongly preferredEducational Requirements• Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Biotechnology, or related field• Advanced academic qualifications considered an advantage• Strong understanding of clinical research methodologies and regulatory frameworksExperience and Skills• Strong clinical trial lifecycle knowledge including design, startup, execution, and close-out• Proven experience in Risk-Based Quality Management (RBQM) and adaptive monitoring• Expertise in centralized monitoring technologies and data visualization dashboards• Thorough understanding of international drug development standards including ICH-GCP• Strong analytical and critical thinking skills to detect patterns, trends, and outliers• Ability to conduct root cause analysis and recommend mitigation actions• Excellent communication and presentation skills with ability to influence stakeholders• Strong leadership capabilities including coaching, mentoring, and performance management• Demonstrated project management and cross-functional collaboration experience• Digital proficiency and data-driven decision-making capability• High attention to detail and accuracy• Strong negotiation and conflict resolution skills• Ability to work independently and deliver high-quality results on timeSalary Insights• Competitive senior-level compensation aligned with global pharmaceutical industry standards• Performance-based incentives and leadership benefits may apply• Opportunities for long-term career growth within Global Clinical OperationsCompany OverviewNovartis is a global healthcare leader committed to reimagining medicine to improve and extend people’s lives. With operations across multiple therapeutic areas and international markets, the company emphasizes scientific innovation, patient safety, and regulatory excellence.Within Global Clinical Operations, Novartis continues to strengthen its centralized monitoring and RBQM capabilities to ensure high-quality clinical trial execution worldwide. The organization promotes diversity, inclusion, and compliance with the highest ethical and quality standards.FAQs• Q: How many team members will the Lead CM manage?A: The role typically manages 5–8 Central Monitors.• Q: Is central monitoring experience mandatory?A: Yes, hands-on experience with centralized monitoring, KRIs, and RBQM frameworks is strongly preferred.• Q: Does the role involve global collaboration?A: Yes, the position collaborates with global clinical teams and stakeholders.• Q: Is people management experience required?A: Yes, a minimum of 3 years of recent leadership or team management experience is required.Application Tips• Clearly highlight centralized monitoring and RBQM experience• Provide examples of KRI design, risk detection, and mitigation strategies• Emphasize leadership and people management achievements• Demonstrate experience with clinical dashboards and analytics platforms• Showcase knowledge of ICH-GCP and global regulatory requirements• Include examples of cross-functional collaboration and stakeholder influence

Why This Role MattersThe Regulatory Affairs Medical Expert provides critical scientific and regulatory support for drug development and marketing authorization processes. This role ensures that clinical, preclinical, and technical data are prepared and submitted accurately to regulatory authorities in India, the U.S., EU, and other targeted regions. By guiding regulatory strategies, reviewing dossiers, and supporting interactions with health authorities and sponsors, the role contributes directly to the successful approval and launch of new medicinal products, diagnostics, and devices.Job DescriptionThe Regulatory Affairs Medical Expert is responsible for defining regulatory strategies, preparing, reviewing, and submitting regulatory dossiers, and liaising with internal teams, sponsors, and health authorities. The role involves ensuring compliance with international regulatory requirements, supporting interdepartmental projects, and maintaining archival systems for all submissions and regulatory guidance. This position requires extensive knowledge of drug development, regulatory frameworks, and scientific evaluation to facilitate approvals and safe market entry of new products.Key Features Of The Role• Define regulatory strategies for submission of clinical trial applications• Develop regulatory approaches for approval and marketing trial applications in India, the U.S., EU, and other targeted regions• Prepare, review, and submit regulatory documents and dossiers containing technical, preclinical, and clinical data in agency-required formats• Respond to questions and inquiries from health authorities in a timely and accurate manner• Support QA audit plans and quality systems management plans• Prepare and review clinical amendments, safety reports, and data for regulatory approval processes• Provide regulatory support to interdepartmental project teams and scientific staff• Liaise with sponsors during preparation of initial regulatory dossiers• Interact with health authorities through telephone contacts, teleconferences, meetings, and submissions• Collaborate with internal scientists on scientific and regulatory issues impacting drug development• Maintain archival systems for all regulatory submissions, contact logs, guidance documents, regulations, and SOPsResponsibilities• Develop and implement regulatory strategies for clinical trial and marketing authorization submissions• Ensure all regulatory submissions comply with local and international guidelines and regulations• Prepare and review dossiers, including integrated efficacy and safety analyses (ISE and ISS)• Support generation of integrated databases, pooled analyses, and regulatory reporting documents• Respond to regulatory authority queries regarding technical, preclinical, and clinical data• Ensure proper maintenance of regulatory documentation, guidance documents, and SOPs• Participate in interdepartmental project teams to provide regulatory expertise and guidance• Support QA audits and quality system management for regulatory processes• Facilitate communication and alignment between sponsors, internal scientists, and health authoritiesRequired QualificationsEducational Requirements• Bachelor’s or advanced degree (MD, Ph.D., Pharm.D.) in scientific, life sciences, or related fieldExperience And Skills• Minimum of 5 years of experience in regulatory affairs, with at least 8 years in drug development• Strong knowledge of international regulations and guidelines governing pharmaceutical development• Experience working with regulatory authorities in India, U.S., EU, or other regions• Expertise in preparation and review of regulatory dossiers, safety reports, and integrated analyses• Excellent communication and interpersonal skills to liaise with sponsors, health authorities, and internal teams• Strong organizational, analytical, and problem-solving skillsSalary Insights• Competitive compensation aligned with experience and industry standards• Performance-based incentives and opportunities for professional development• Exposure to global regulatory processes, drug development, and cross-functional projectsCompany OverviewThe organization is a global pharmaceutical and biotechnology company focused on delivering innovative therapies and diagnostics worldwide. It emphasizes regulatory compliance, scientific rigor, and collaborative teamwork to bring new medicines to patients. Employees are empowered to contribute to drug development strategies, regulatory submissions, and high-impact projects in a dynamic, international environment.FAQsQ: What types of submissions will I work on?A: Clinical trial applications, marketing authorization applications, regulatory dossiers, safety reports, and integrated analyses for regulatory submissions in India, the U.S., EU, and other regions.Q: Will I interact with external agencies?A: Yes, the role requires communication with health authorities, sponsors, and international regulatory agencies.Q: Is prior regulatory experience required?A: Yes, candidates should have at least 5 years of regulatory affairs experience with 8 or more years in drug development.Q: Does this role involve QA and documentation management?A: Yes, the role supports QA audits, quality systems management, and maintains archival systems for all regulatory submissions and guidance documents.Application Tips• Highlight experience in regulatory affairs, dossier preparation, and drug development• Emphasize knowledge of international regulatory guidelines (India, U.S., EU)• Showcase experience in clinical, preclinical, and technical data review and submission• Demonstrate ability to liaise with sponsors, internal teams, and health authorities• Include examples of successful regulatory submissions and approvals

Roles & Responsibilities• Review prepay claims with corresponding medical records to determine payment accuracy• Evaluate applicable policies, CPT guidelines, and contracts related to clinical review• Investigate and resolve instances of healthcare fraud and abuse• Provide coding guidance to investigators on CPT codes relevant to investigations• Document findings using information from tips, member benefits, and medical records• Participate in regulatory meetings with clients and discussions with providers, advocates, and legal teams• Monitor claim inventory to ensure adherence to performance guarantees and targets• Assist in internal and external projects, analyze data, and collaborate with stakeholders for resolution• Mentor junior staff and provide guidance on complex coding and investigation issues• Maintain compliance with company policies, employment terms, and regulatory requirementsQualification• Graduate of minimum 4-year course in Allied Medical Health• Certified Professional Coder (CPC)• CPT & ICD coding experience or must pass AAPC CPC Certification provided by the organizationExperience• 1+ year clinical or coding experience (surgical, hospital, or clinic settings)• 1+ year BPO experience• Experience in health insurance billing/coding preferredSkills• Strong knowledge of CPT and ICD coding guidelines• Critical thinking, analytical, and problem-solving skills• Proficiency in PC-based software• Ability to manage multiple tasks and prioritize effectively• Strong oral and written communication skills• Ability to work collaboratively in a team environmentAbout The CompanyOptum, part of UnitedHealth Group, is a global healthcare organization delivering technology-enabled health services, pharmacy benefits, and data-driven solutions. The company focuses on improving health outcomes, advancing equitable care, and transforming healthcare systems worldwide through innovation, compliance excellence, and operational expertise.

Roles & Responsibilities• Maintain and update clinical trials databases with accurate and validated information• Analyze and cross-reference data from trial registries, scientific conferences, press releases, and research publications• Track pharmaceutical drug pipelines and monitor clinical development phases• Interpret complex clinical studies and drug-related data• Perform secondary research related to clinical and pharmaceutical intelligence• Ensure high data accuracy within clinical trial intelligence platforms• Deliver weekly productivity and quality targets• Validate and standardize clinical information for structured database entry• Support ongoing enhancements to clinical intelligence workflows• Collaborate with internal teams to maintain data integrity and reporting standardsQualification• B.Pharm (Bachelor of Pharmacy)• M.Pharm (Master of Pharmacy)• M.Sc (Biotechnology / Microbiology)Experience• Fresher or up to 6 months of experience in clinical report analysis or clinical data updating• Exposure to secondary research in clinical or pharmaceutical domains (preferred)Skills• In-depth understanding of clinical trials and drug development phases• Knowledge of pharmaceutical drug pipelines• Strong analytical and problem-solving skills• Excellent written and verbal English communication• High attention to detail and data accuracy• Ability to interpret complex clinical and regulatory informationAbout the OrganizationClarivate provides trusted insights and analytics across life sciences, healthcare, academia, and intellectual property sectors. Through platforms such as Cortellis Clinical Trial Intelligence and Cortellis Drug Discovery Intelligence, Clarivate delivers comprehensive clinical and drug development data to support pharmaceutical research, competitive intelligence, and strategic decision-making.

Roles & Responsibilities• Collaborate with Global Medical Services and operational teams for budget development• Review study protocols and schedules of assessments• Prepare accurate cost estimates using internal proposal tools• Interpret clinical research phases and service requirements• Maintain and update proposal development tools and supporting documentation• Communicate with internal stakeholders to clarify scope, assumptions, and timelines• Support financial modelling and budget tracking activities• Ensure compliance with company policies, SOPs, and regulatory standards• Contribute to process improvements within proposal and budgeting workflows• Provide analytical support for medical services cost planningQualification• Bachelor’s Degree in Life Sciences, Business, Economics, Finance, or related field• Equivalent relevant professional experience considered• Bachelor of Pharmacy, Master of PharmacyExperience• 2–5 years of experience in Clinical Research (including CRA roles), Proposal Development, Pharma Finance/Analytics, or Medical/Safety/Pharmacovigilance Services• Experience in budget preparation or cost estimation within clinical research (preferred)Skills• Strong analytical and numerical skills• Advanced proficiency in Microsoft Excel and spreadsheet modelling• Understanding of clinical research phases and trial operations• Excellent written and verbal communication skills• Ability to work effectively within a matrix organizational structure• High attention to detail and problem-solving capabilityAbout the OrganizationParexel is a leading global Contract Research Organization (CRO) providing clinical development, regulatory consulting, and commercialization services to the pharmaceutical and biotechnology industries. With a strong international presence, Parexel supports the development of innovative therapies through expert-driven clinical and operational solutions.

Roles & Responsibilities• Involvement in the country and site selection process with the Registries Team and Local Medical Affairs.• Arrange the supply of necessary Registry materials (e.g., Protocols, Case Report Forms, Protocol Agreement Forms) for ethical and regulatory submissions.• Ensure financial contracts are executed for each site and assist with the contracting process.• Maintain oversight of Registries in assigned countries and provide country status to the Global Registries Team.• Coordinate and collaborate with Clinical Research Associates.• Review and approve site visit reports, follow-up letters, etc.• Monitor data quality and prepare project tracking and reporting systems.• Ensure adequate safety reporting process in compliance with country regulations and SOPs.• Implement Corrective and Preventive Actions (CAPA) when necessary.• Train new CRAs and temporary resources.• Maintain tables, trackers, and databases to follow the study progress locally and globally.• Support the improvement of internal processes and ensure TMF compliance.• Align with internal and external stakeholders to prioritize Registry study activities.Qualification• Degree in Pharma/Scientific Discipline or related Life Science degree.• Project management certification preferred.Experience• 5+ years of experience in Clinical Research & Development, including at least 2 years in clinical trial project management.Vacancies• 1 Clinical Project Lead position available.Skills• Strong project management, leadership, and negotiation skills.• Excellent communication skills (written and oral).• Proficiency in ICH-GCP principles, CTMS, EDC systems, and FDA regulations.• Experience in clinical trial project management and drug development.• Ability to work across global projects and in an international matrix environment.• Strong analytical, quantitative, and problem-solving skills.• Cross-functional collaboration skills.About the CompanySanofi S.A. is a global healthcare company that focuses on advancing science and providing innovative solutions for patient care. With a strong commitment to improving global healthcare access, Sanofi operates across several therapeutic areas and is known for its contributions to clinical research and development. The company fosters a collaborative work environment where employees are encouraged to innovate and grow professionally.

Roles & Responsibilities:• Conduct site feasibility and identify potential investigators• Negotiate study budgets and finalize investigators, sites, CDA, and study contracts• Prepare and submit study documents for Ethics Committee (EC) approvals• Oversee investigational product (IP) dispensing, inventory management, and reconciliation• Ensure timely site initiation, monitoring, and close-out visits with proper documentation• Train investigators and site staff on study protocol, procedures, and GCP principles• Monitor patient recruitment, data entry, SDV, and query resolution• Ensure timely reporting of SAEs and SUSARs in compliance with regulatory and PV policies• Identify site risks, perform analysis, and implement CAPA where required• Coordinate with in-house teams or CRO partners for data management, statistical analysis, and database lock (DBL) activitiesQualification:• Bachelor’s or Master’s degree in Life Sciences (Biology, Chemistry, Nursing, Pharmacy, Public Health, etc.)• OR Postgraduate Diploma in Clinical ResearchExperience:• 1–5 years of relevant experience in Clinical ResearchSkills:• Strong knowledge of GCP guidelines and clinical trial regulations• Experience in Phase III and Phase IV clinical trials• Site management and monitoring expertise• Understanding of SAE/SUSAR reporting processes• Cross-functional collaboration skills• Good communication and documentation abilities• Strong analytical and problem-solving skillsAbout the Organization:Sun Pharmaceutical Industries Ltd is one of the world’s leading specialty generic pharmaceutical companies with a strong global presence. The organization focuses on innovation, quality, and patient-centric healthcare solutions while fostering a culture of growth, ownership, and collaboration.

Roles & Responsibilities:• Process and upload regulatory correspondence (letters, emails, meeting minutes) into RIM systems in alignment with eCTD structure• Ensure accurate metadata classification and identify regulatory commitments and health authority deadlines• Extract structured data from FDA Summary Basis of Approval (SBA) documents, including trial design, sample size, and dosing details• Capture clinical endpoints, statistical outcomes (P-values, Hazard Ratios, Confidence Intervals), and regulatory conclusions• Identify and document key regulatory milestones such as Breakthrough Therapy, Orphan Drug Designation, and RMAT• Review and summarize Advisory Committee meeting content, voting results, and key discussions• Maintain database consistency through cross-referencing FDA sources (e.g., Drugs@FDA) using standardized terminology• Support internal audits and health authority inspections through efficient document retrieval and data accuracy• Ensure RIM database serves as a single source of truth with 100% data integrityQualification:• Bachelor’s / Master’s degree or Pharm D in Life Sciences, Pharmacy, Clinical Research, or related disciplineExperience:• 2–4 years of experience in Regulatory Operations, Regulatory Information Management, Document Management, or Clinical ResearchSkills:• Strong understanding of drug development lifecycle and global health authorities (FDA, EMA, etc.)• Good knowledge of FDA CDER/CBER approval package structures• Ability to interpret clinical trial data (double-blind studies, ITT analysis, non-inferiority trials)• Hands-on experience with RIM tools such as Veeva Vault (preferred)• Proficiency in MS Excel, Google Sheets, and document management systems• Excellent written English with strong summarization skills• High attention to detail and ability to manage high-volume work under strict timelinesPreferred:• Certification or PG Diploma in Regulatory Affairs• Experience supporting audits and regulatory inspectionsAbout the Organization:Roche is a global healthcare leader committed to innovation, inclusion, and patient-centric solutions. Roche Services & Solutions enables Roche teams worldwide by delivering high-quality end-to-end business services with a OneRoche mindset.

Roles & Responsibilities• Manage volunteer registration and screening processes• Coordinate with diagnostic laboratories for clinical reports• Conduct and support the informed consent process for study volunteers• Perform volunteer enrolment activities as per study protocol• Monitor volunteers throughout the study duration• Support investigational product administration activities• Manage volunteer discharge activities as per protocol requirements• Compile, maintain, and update study documents and Trial Master File (TMF)Qualification• B.Pharm / M.PharmExperience• 2–3 years of relevant experience in clinical research or clinical pharmacology studiesNo. of Positions: 07Skills• Good understanding of clinical trial processes and GCP guidelines• Strong documentation and coordination skills• Attention to detail and ability to follow protocols• Effective communication and teamwork skillsAbout the OrganizationJeevan Scientific Technology Limited is a leading life sciences services company offering integrated solutions in clinical research, bioavailability and bioequivalence studies, regulatory, and quality services, supporting global pharmaceutical and biotech organizations.

Roles & Responsibilities• Serve as primary point of contact between Sponsor and JSTL for clinical trial projects• Develop and manage Master Service Agreements (MSA) in coordination with Sponsors• Provide guidance on MSA terms to all Functional Leads• Develop and maintain SOPs for clinical trial project management• Lead project initiation involving Sponsors, Functional Leads, CRAs, Investigators, and site staff• Supervise CRAs in site selection, contracts, budget negotiations, and regulatory submissions• Oversee site start-up, monitoring, execution, and close-out activities• Ensure compliance with national/local regulations, ICH-GCP guidelines, and JSTL SOPs• Monitor regulatory updates and ensure implementation of changes impacting clinical trials• Ensure audit and inspection readiness of sites and follow-up on audit findings• Manage project timelines, milestones, budgets, and resource allocation• Provide periodic project assessments and progress reports to Sponsors and leadership• Maintain MSAs and project metrics using Microsoft management tools• Manage internal and external resources including vendors and third-party contractors• Support hiring, training, performance management, and retention of clinical operations staffQualification• Master’s degree in Life Sciences• Advanced degree (MS Pharmacy / PharmD / PhD / MD) preferred• Certification in Clinical Trial Project Management preferredExperience• 3–5 years of experience in clinical trial project management• Experience managing Phase I–IV clinical trials preferred• Prior experience in CRO or pharmaceutical industry desirableSkills• Strong written and verbal communication skills• Excellent stakeholder and sponsor management capabilities• Strong planning, organizational, and multitasking abilities• Ability to work independently in a regulated, patient-focused environment• Strong analytical, critical thinking, and decision-making skills• Ability to manage cross-functional and diverse teams with integrity• Proficiency in Microsoft Project Manager and related IT tools for metrics and reportingAbout the OrganizationJeevan Scientific Technology Limited is a global life sciences services organization providing integrated solutions in clinical research, regulatory affairs, project management, pharmacovigilance, and medical writing, supporting pharmaceutical and biotech companies across the full clinical development lifecycle.

Roles & Responsibilities• Act as regulatory lead on assigned projects and collaborate with cross-functional teams (Clinical, Data Management, Biostatistics, Operations)• Prepare Clinical Study Reports (CSRs), clinical summaries, protocol summaries, and regulatory responses• Interpret and understand clinical trial protocols, study design, data analysis, timelines, and patient recruitment• Coordinate document review, approvals, QC, and submission activities• Arrange and lead internal and external document review meetings• Independently resolve content and scientific issues during document development• Develop scientific publications including manuscripts, abstracts, posters, and oral presentations• Provide project and timeline management support for ongoing programs• Ensure timely delivery of regulatory submissions and updates to leadership• Communicate progress, milestones, risks, and resource needs to management• Ensure compliance with ICH, CDSCO, and applicable regulatory guidelines and SOPs• Identify and implement process improvements• Mentor junior writers and oversee internal teams or external vendorsQualification• Bachelor’s degree in Life Sciences with significant writing experience• Advanced degree (MS Pharmacy / PharmD / PhD / MD) preferred• Certification in Regulatory Affairs and/or Medical Writing preferredExperience• 2–4 years of industry experience in regulatory or medical writing• Experience in healthcare, CROs, academia, or related areas such as clinical research, regulatory, quality, or R&DSkills• Strong knowledge of clinical development processes and ICH-GCP guidelines• Expertise in regulatory and clinical document writing• Working knowledge of statistical concepts and data interpretation• Excellent written and verbal communication skills• High attention to detail with strong editing and peer-review abilities• Experience with CTD templates and electronic document management systems• Proficiency in MS Word, PowerPoint, Excel, and Adobe Illustrator• Strong project management, coordination, and mentoring skillsAbout the OrganizationJeevan Scientific Technology Limited is a global life sciences services company delivering integrated solutions across clinical research, regulatory affairs, pharmacovigilance, and medical writing, supporting pharmaceutical and biotech organizations throughout the product lifecycle.

Roles & Responsibilities• Collect, review, and process Adverse Event (AE) and Serious Adverse Event (SAE) reports• Perform case processing and data entry in drug safety databases• Ensure accuracy, completeness, and timeliness of safety case documentation• Conduct literature search and review for safety-relevant information• Assist in signal detection, risk assessment, and safety evaluations• Support preparation and submission of safety reports such as PSURs and DSURs• Ensure compliance with ICH-GCP, ICH-E2B, and global regulatory guidelines• Coordinate with cross-functional teams including Clinical, Regulatory, and Quality• Maintain safety records and support audit and inspection readinessQualification• Bachelor’s degree in Pharmacy, Life Sciences, Nursing, or a related disciplineExperience• 0 to 2 years of experience in Pharmacovigilance or Drug Safety• Freshers with relevant academic knowledge may also applySkills• Basic knowledge of pharmacovigilance and drug safety concepts• Understanding of AE/SAE reporting and regulatory requirements• Good written and verbal communication skills• Strong attention to detail and analytical skills• Ability to work independently and in a team environment• Proficiency in MS Word, Excel, and safety databases is an advantageAbout the OrganizationJeevan Scientific Technology Limited is a leading life sciences and healthcare solutions company offering services across pharmacovigilance, clinical research, regulatory affairs, and data management. The organization supports global pharmaceutical and biotech companies with high-quality, compliant, and technology-driven solutions.

Roles & Responsibilities• Contribute at different levels to execution of Evidence Synthesis projects, including search strategy development, screening, and data extraction• Develop a comprehensive understanding of disease areas and treatment paradigms through primary and secondary research• Independently generate evidence to support selection, development, and implementation of fit-for-purpose COA instruments• Perform gap analyses, statistical analyses, psychometric validation, and dissemination of COA evidence• Prepare scientific documents such as reports, regulatory documents, and publications for internal and external use• Support COA endpoint strategies aligned with Best-in-Class / First-in-Class product development• Act as a subject matter expert (SME) to guide team members in executing COA-related projects• Identify opportunities to innovate COA value identification, evidence generation, and dissemination processes• Contribute to Target Value Propositions with patient-centric outcomes and value messaging• Develop and maintain strong expertise in COA science and methodologies• Collaborate effectively with global COA leads across multiple time zones• Lead or support literature reviews, qualitative research, COA landscape analyses, and instrument validation studies• Support development of COA dossiers and provide strategic input• Contribute to development of COA evidence generation processes, templates, and standards in line with FDA and EMA guidance• Work closely with HEVA, RWE, Clinical, Medical Affairs, Marketing, External Affairs, and Market Access teams• Prepare customized COA deliverables for global and local stakeholdersQualification• Advanced degree in Life Sciences, Pharmacy, Public Health, Psychology, or related disciplineExperience• Minimum 5+ years of experience in COA science• Experience in COA data analysis, COA instrument development or validation, and endpoint strategy• Experience in pharmaceutical industry, CRO, consultancy, or academiaSkills• Strong analytical skills to synthesize qualitative and quantitative data• Expertise in COA methodologies, psychometric validation, and patient-centered outcomes• Excellent scientific writing and communication skills• Stakeholder management and cross-functional collaboration• Ability to work independently and lead projects in a global environment• Exceptional proficiency in written and spoken EnglishAbout the OrganisationSanofi is a global biopharmaceutical company dedicated to chasing the miracles of science, fostering innovation, inclusivity, and long-term career growth while delivering patient-focused healthcare solutions worldwide.

Roles & Responsibilities• Support HEVA teams in assigned therapy area portfolios to plan and generate robust health economics and value-based evidence from global and US perspectives• Contribute to execution of high-quality research projects, economic models, and trial design recommendations• Support development of HEVA evidence generation strategies across pre-launch, launch, and post-launch phases• Work on studies including burden of illness, epidemiology, literature reviews, meta-analyses, retrospective and prospective observational studies, economic evaluations, and patient-reported outcomes• Support execution and management of approved HEVA studies under guidance of managers or product leads• Assist in development of Core Value Dossiers (CVD) and US AMCP dossiers• Identify and implement innovative approaches to evidence generation and dissemination to enhance payer value propositions• Develop and maintain strong therapeutic area expertise• Collaborate with global HEVA teams across multiple time zones• Work closely with RWE, Clinical, Medical Affairs, Marketing, External Affairs, and Market Access teams to identify evidence needs• Support preparation of customized, stakeholder-specific HEVA deliverables• Assist in development of strategic HEVA evidence materials, templates, and processes• Ensure adherence to HEVA evidence generation guidelines, HTA standards, and regulatory requirementsQualification• Advanced degree in Life Sciences, Pharmacy, or related discipline• OR Medical degreeExperience• Minimum 5+ years of experience in Health Economics and Outcomes Research (HEOR)• Experience in pharmaceutical industry, CRO, consultancy, or academiaSkills• Strong analytical skills to translate clinical and economic data into payer-focused evidence strategies• Solid understanding of reimbursement decision-making and value drivers across payer types• Knowledge of health economics methodologies and HTA review processes• Excellent scientific writing and communication skills• Stakeholder management and cross-functional collaboration• Ability to work independently and within global team environmentsAbout the OrganizationSanofi is a global biopharmaceutical company driven by science and innovation, committed to delivering transformative medicines and vaccines while fostering inclusive growth, collaboration, and long-term career development opportunities for its people worldwide.

Roles & Responsibilities• Contribute to execution of Evidence Synthesis projects including search strategy development, literature screening, and data extraction• Generate robust clinical, economic, and humanistic evidence to support global and local programs/products• Support pre-launch, launch, and post-launch evidence generation for investigational and marketed drugs• Contribute to studies such as burden of illness, epidemiology, literature reviews, meta-analyses, observational studies, economic evaluations, and patient-reported outcomes• Support execution and management of approved HEVA/Medical studies under guidance of product leads• Assist in development of Core Value Dossiers (CVD) and AMCP dossiers• Identify opportunities to innovate evidence generation and dissemination processes to improve payer access and reimbursement outcomes• Develop and maintain therapeutic area expertise• Collaborate with global HEVA, Medical, RWE, Clinical, Market Access, and Commercial teams across regions• Support preparation of customized evidence-based deliverables for internal stakeholders• Contribute to development of strategic evidence materials, templates, and processes• Ensure adherence to evidence generation guidelines and scientific standardsQualification• Advanced degree in Life Sciences, Pharmacy, or related discipline• OR Medical degreeExperience• Minimum 3+ years of experience in Health Economics and Outcomes Research (HEOR)• Experience in pharmaceutical industry, CRO, consultancy, or academiaSkills• Strong analytical skills to translate clinical and economic data into payer-focused evidence strategies• Excellent scientific writing and communication skills• Stakeholder management and cross-functional collaboration• Ability to work independently and in global team environments• External engagement and project coordination skillsAbout the OrganisationSanofi is a global biopharmaceutical company committed to discovering, developing, and delivering innovative medicines and vaccines, driven by science and dedicated to improving health outcomes for patients worldwide.

Roles & Responsibilities• Support HEVA teams across assigned therapy areas to plan and generate robust health economics and value-based evidence from global and US perspectives• Contribute to execution of HEOR research projects including economic models, trial design inputs, and value evidence generation• Assist in pre-launch, launch, and post-launch evidence generation activities for investigational and marketed products• Support studies such as burden of illness, epidemiology, literature reviews, meta-analyses, observational studies, economic evaluations, and PROs• Assist in execution and management of approved HEVA studies under guidance of HEVA leads• Support development of Core Value Dossiers (CVD) and AMCP dossiers• Contribute to development of HEVA strategic evidence materials, templates, and processes• Maintain adherence to HEVA evidence generation guidelines and scientific standards• Collaborate with HEVA, RWE, Clinical, Medical Affairs, Marketing, External Affairs, and Market Access teams globally• Support preparation of customized HEVA deliverables for internal and external stakeholders• Develop and maintain therapy area expertise• Build and sustain effective relationships with global HEVA stakeholders across time zonesQualification• Advanced degree in Life Sciences, Pharmacy, or related discipline• OR Medical degreeExperience• Minimum 3+ years of experience in HEOR• Experience in pharmaceutical industry, CRO, consultancy, or academiaSkills• Strong analytical skills to translate clinical and economic data into payer-focused evidence strategies• Excellent scientific writing and communication skills• Stakeholder management and cross-functional collaboration• Ability to work independently and within global teams• External engagement and project coordination skillsAbout the OrganisationSanofi is a global biopharmaceutical company focused on discovering, developing, and delivering innovative medicines and vaccines, committed to improving health outcomes worldwide through science-driven, patient-centric solutions.

Roles & Responsibilities:• Ensure timely and accurate delivery of commercial and pharmaceutical datasets by collaborating with stakeholders• Maintain data availability, quality, completeness, and consistency across systems and downstream teams• Identify data gaps and develop SOPs for data management processes and enhancements• Support forecasting, targeting, call planning, field reporting, incentive compensation, and market mix activities• Monitor data quality reports, investigate discrepancies, and maintain business rules and metadata• Provide first-level support for sales, MDM, and omnichannel data queries• Develop analytical tools, automation processes, and reporting capabilities• Refresh periodic reports and ensure compliance with data governance and operational standards• Collaborate with global teams and vendors to ensure efficient end-to-end project deliveryQualification:• Bachelor’s degree in Engineering, Statistics, Life Sciences, Business Analytics, Management, or related field• Advanced degree (MBA/Masters/PhD) preferredExperience:• 2–3+ years of experience in pharmaceutical commercial datasets and data management• Experience working with syndicated pharma data sources preferredSkills:• Knowledge of pharmaceutical data sources such as IQVIA, Veeva, OneKey, Xponent, or similar• Hands-on experience with AWS, Snowflake, SQL, Python, Informatica, or Dataiku• Understanding of data governance, stewardship, and data quality frameworks• Proficiency in Excel, Power BI, VBA, or Alteryx• Strong analytical, communication, and stakeholder management skills• Ability to translate business requirements into data solutionsAbout the Organization:Sanofi is a global healthcare company dedicated to improving patient outcomes through innovative medicines, vaccines, and digital healthcare solutions. The organization leverages advanced analytics, technology, and data-driven insights to transform commercialization processes and drive better healthcare decisions worldwide.

Roles & Responsibilities:• Maintain regulatory SharePoint workspaces and support Global Regulatory Team (GRT) member transitions• Coordinate cross-functional regulatory activities and generate internal milestone/progress reports• Perform basic regulatory intelligence analyses to support regulatory strategy• Support Module 1 documentation for ex-US and ex-EU submissions• Coordinate registration samples, regulatory deliverables, and request certificates from FDA, EMA, Swissmedic• Manage document scanning, shipping, and submission logistics• Upload documents to Virtual Data Rooms (VDRs) and track product deletion notifications to Health Authorities• Support asset integration, metadata remediation, and response to Health Authority queries• Schedule RRT meetings, prepare response templates, and assist in submission publishing• Assist in preparation of monthly regulatory dashboards and track submissions, approvals, milestones, and achievementsQualification: Bachelor’s degree in Pharmacy, Life Sciences, Natural Sciences, or Healthcare-related fieldExperience: 0–2 years in the pharmaceutical industrySkills: Knowledge of global Module 1 regulatory requirements; basic understanding of FDA, EMA, and international regulations; familiarity with Veeva Vault Regulatory Operations; exposure to CMC variations and HA queries; strong documentation, organizational, and communication skills; proficiency in MS Office and Outlook; excellent command of EnglishAbout the Organization:Bristol Myers Squibb (BMS) is a global biopharmaceutical leader committed to discovering, developing, and delivering innovative medicines that help patients worldwide. This Hyderabad role provides early-career regulatory professionals exposure to global submissions, portfolio analytics, and health authority interactions in a collaborative and growth-oriented environment.