Clinical Research Jobs

Roles & Responsibilities• Support global study teams with Trial Master File (TMF) maintenance• Manage and update Veeva Vault, CTMS, and EDC systems• Assist in Ethics Committee (EC) and Health Authority (HA) submissions• Track essential documents and clinical trial milestones• Coordinate study meetings, training documentation, and trial communications• Support site start-up activities and regulatory document collection• Maintain inspection-ready documentation for audits and inspections• Liaise with vendors, internal teams, and site personnel• Ensure compliance with ICH-GCP and global regulatory standardsQualification• Bachelor of Pharmacy• Bachelor’s degree in Life Sciences / Pharmacy / Biotechnology or related fieldExperience• 1–2 years of experience as a Clinical Trial Assistant (CTA)• Hands-on experience in EC & HA submissions• Experience in site payments tracking and essential clinical documentationSkills• Strong understanding of ICH-GCP guidelines and global clinical operations• Proficiency in Veeva Vault, CTMS, and EDC platforms• Excellent documentation and organizational skills• Strong communication and coordination abilities• Ability to manage multiple tasks in a fast-paced global CRO environment• High attention to detail and compliance focusAbout the CompanyICON plc is a global Contract Research Organization (CRO) providing clinical development and commercialization services to pharmaceutical and biotechnology companies, supporting global clinical trials with regulatory excellence and operational expertise.

Roles & Responsibilities• Deliver engaging online training sessions on Clinical Data Management for students and professionals• Develop and update course materials including presentations, handouts, assignments, and case studies• Provide practical examples and real-world scenarios to enhance learning outcomes• Conduct assessments, evaluate student performance, and provide constructive feedback• Stay updated with industry trends, CDM tools, and regulatory advancements• Collaborate with internal teams to improve course structure and training delivery• Mentor learners and guide them toward career opportunities in Clinical Data ManagementQualification• Master’s degree in Clinical Data Management, Life Sciences, or related field• Strong knowledge of clinical trial processes and CDM tools• Knowledge of regulatory guidelines such as GCP, FDA, and ICHExperience• Minimum 2+ years of hands-on experience in Clinical Data Management• Prior teaching or training experience preferredSkills• Strong understanding of clinical trial lifecycle and data management processes• Excellent presentation and communication skills• Ability to simplify complex clinical concepts• Proficiency in MS Office and online teaching platforms• Analytical and mentoring skillsAbout The CompanyBioTecNika is a leading biotechnology and life sciences training organization in India, dedicated to empowering students and professionals through industry-focused education programs. The company offers specialized training, career guidance, and skill development initiatives across biotechnology, clinical research, and clinical data management domains, helping learners build successful careers in the life sciences sector.

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:• Track and identify clinical resource needs across projects• Manage staff assignments, availability, and project module updates• Maintain resourcing dashboards and forecasting tools• Forecast labor needs across different geographical regions• Identify and allocate staff based on therapeutic area expertise• Align resource assignments with client and project requirements• Update roll-off dates and staffing projections• Prepare utilization, forecasting, and projection reports using Excel and dashboards• Support RFP submissions and bid defense meetings with resourcing data• Track and distribute updated CVs for project allocation• Coordinate with internal departments for documentation and staffing updates• Support quality control of departmental reports and resource documentationQualification:• Bachelor of Pharmacy• Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, or related field preferred• Equivalent education and training combinations consideredExperience:• 0–2 years of relevant experience in clinical operations, resourcing, or data analysisSkills:• Proficiency in MS Office (Advanced Excel & Outlook preferred)• Strong quantitative and analytical abilities• Excellent attention to detail and accuracy• Ability to manage multiple projects simultaneously• Strong written and verbal communication skills• Basic understanding of clinical trial operations (preferred)About the Organization:Thermo Fisher Scientific, through its PPD clinical research services, is a global leader in life sciences and clinical research solutions, supporting pharmaceutical and biotech companies across the drug development lifecycle.

Roles & Responsibilities:• Conduct Analytical, Physicochemical, and Five-Batch Analysis studies in compliance with regulatory requirements• Ensure adherence to OECD GLP principles and applicable international test guidelines (OECD, EPA, OPPTS, CIPAC, WHO/FAO, etc.)• Act as Study Director responsible for planning, execution, monitoring, and reporting of assigned studies• Serve as the primary point of contact for sponsor queries, optimization requests, and regulatory requirements• Support method development, procedure optimization, and standardization activities• Review and approve study protocols, raw data, and final reports ensuring regulatory readiness• Maintain effective cross-functional coordination with analytical, QA, and regulatory teams• Ensure laboratory safety compliance and proper hazardous waste management• Support audits, inspections, and regulatory submissions as requiredQualification:• M.Sc / M.Pharm (Master of Pharmacy) in Chemistry, Analytical Chemistry, or related disciplinesExperience:• 3–8 years of experience in a GLP-certified CRO environment• Hands-on expertise in analytical and physicochemical testing, preferably including Five-Batch Analysis for agrochemicalsSkills:• Strong understanding of Study Director responsibilities under GLP framework• In-depth knowledge of international regulatory guidelines (OECD, EPA, OPPTS, CIPAC, WHO/FAO)• Excellent analytical, problem-solving, and decision-making skills• Strong documentation and regulatory reporting capabilities• Effective sponsor communication and stakeholder management skillsAbout the Organization:Anthem Biosciences is a leading GLP-certified CRO specializing in pre-clinical research and development services across pharmaceuticals and agrochemicals, committed to delivering high-quality, regulator-ready data through global compliance standards.

Roles & Responsibilities:• Extract structured drug data from public sources like Clinical Trials gov, regulatory filings, and company reports• Analyze regulatory submissions from FDA, EMA, and other global agencies• Apply knowledge of therapeutic areas and mechanisms of action (MoAs)• Follow SOPs to maintain structured publishing workflows• Validate regulatory and clinical data for accuracy and completeness• Meet productivity targets while maintaining high data integrity• Use internal authoring tools for pharma R&D content developmentQualification:• Bachelor of Pharmacy (B.Pharm)• Master of Pharmacy (M.Pharm)• Doctor of Pharmacy (Pharm.D)• Graduate / Postgraduate / Doctorate in Life Sciences, Pharmacy, or Medical SciencesExperience:• Minimum 1 year experience in pharmaceutical research or clinical dataSkills:• Understanding of regulatory databases (FDA, EMA, Clinical Trials gov)• Knowledge of drug development lifecycle and therapeutic areas• Strong MS Excel & Word proficiency• Experience in clinical trial data extraction, drug pipeline intelligence, regulatory database research, or pharmaceutical content developmentAbout the Organization:Norstella is a global life sciences data and AI solutions provider supporting pharmaceutical and biotech companies across the entire drug development lifecycle — from pipeline to patient access.

Roles & Responsibilities:• Coordinate parallel clinical trials alongside hospital workflows• Observe and document NICU clinical data accurately within the system• Track workflow coverage and ensure data completeness• Monitor clinical trial progress and compliance• Identify usability issues and workflow gaps• Act as a coordination bridge between clinicians and product teams• Support structured documentation for product validationQualification:• Basic understanding of hospital or NICU workflows (preferred)• Life Sciences, Biomedical Engineering, Clinical Research, Biotechnology, Nursing, or related healthcare disciplines• Master of Pharmacy, Doctor of Pharmacy, Bachelor of PharmacyExperience:• Internship / Fresher – practical exposure in clinical trials, hospital workflows, or product validation is desirableSkills:• Strong documentation and structured reporting skills• High attention to detail• Comfort working in clinical settings with confidentiality compliance• Clear communication and coordination abilities• Marathi/Hindi language proficiency (mandatory)About the Organization:Phoenix Medical Systems is a reputed healthcare technology company focused on innovative neonatal and clinical care solutions, providing interns hands-on exposure to NICU software validation and clinical workflow integration.

Roles & Responsibilities:• Conduct and oversee site initiation, interim monitoring, and close-out visits according to study protocols, GCP, and applicable regulatory guidelines• Build and maintain strong professional relationships with investigators, site coordinators, and key stakeholders• Proactively identify and resolve site issues to ensure quality and compliance• Perform comprehensive monitoring visits to assess site performance, data accuracy, and adherence to protocol• Ensure timely follow-up on monitoring findings, query resolution, and documentation in compliance with SOPs• Support risk-based monitoring activities and provide oversight to ensure data reliability• Ensure all trial activities comply with study protocols, SOPs, and local/international regulations• Participate in preparation and review of regulatory submissions and ethics committee communications• Monitor, document, and report adverse events according to safety protocols and regulatory timelines• Collaborate with data management and project teams to maintain high data quality and consistency• Participate in internal and external audits, ensuring readiness and corrective actions as needed• Provide ongoing training, mentoring, and support to site staff and junior CRAs• Serve as a subject matter expert for protocol-related and operational queriesQualification:• Bachelor of Pharmacy, Master of Pharmacy• Bachelor’s or Master’s degree in Life Sciences or a related fieldExperience:• Minimum 3 years as a Clinical Research Associate with demonstrated success in independently managing clinical sitesSkills:• Strong understanding of ICH-GCP, local and international regulatory requirements, and clinical trial conduct• Excellent communication and interpersonal abilities• Strong analytical, organizational, and problem-solving skills• Proficiency in documentation, reporting, and time management• Ability to work independently and collaboratively within cross-functional teams• Willingness to travel extensively to investigative sitesAbout the Organization:MS Clinical Research (MSCR) is a leading clinical research organization dedicated to advancing scientific innovation and improving healthcare outcomes through high-quality clinical trials that meet global standards.

Roles & Responsibilities:• Assist Project Manager and Clinical Research Associates (CRAs) in updating and maintaining clinical systems to track site compliance and performance within project timelines• Help the clinical team in preparing, handling, distributing, filing, and archiving clinical documentation and reports according to SOPs• Assist with periodic review of study files for accuracy and completeness• Track and manage Case Report Forms (CRFs), queries, and clinical data flow• Process Data Collection Forms including login, tracking, and quality control as appropriate for the study• Assist in preparing Quality Management System documentation and support audit preparations• Provide general administrative support to the Clinical Operations Department• Support Clinical teams in completing all required tasks to meet departmental and project goals• Set up, organize, and maintain clinical study documentation (e.g., Main Study Files, CRFs) including preparation for audits, reconciliation, and archival• Assist in coordinating Investigator payments, if applicable• Support preparation of slides, overheads, and presentations for projects, departmental meetings, sponsors, and business developmentQualification:• Bachelor of Pharmacy, Master of Pharmacy• Degree or equivalent experience in a Clinical Background (Life Sciences, Pharmacy, Clinical Research, etc.)Experience:• 2–3 years of professional experience in clinical research or medical device trialsSkills:• Strong understanding of medical device regulations• Excellent written and verbal communication skills• Familiarity with clinical systems and documentation standardsAbout the Organization:Concept Medical is a globally recognized medical device company specializing in innovative interventional technologies, playing a key role in advancing cardiovascular and endovascular treatment solutions.

Roles & Responsibilities• Manage end-to-end Clinical Data Management (CDM) activities for global clinical trials• Perform User Acceptance Testing (UAT) for EDC systems (Medidata RAVE)• Oversee study conduct and ongoing data review cycles• Handle query management and discrepancy resolution• Conduct data validation and review edit checks• Support database freeze, lock, and close-out activities• Coordinate with Clinical Research Associates (CRAs), Project Managers (PMs), and sponsor teams• Ensure compliance with ICH-GCP guidelines and data integrity standards• Assist in study close-out and archival procedures• Maintain accurate documentation across the clinical database lifecycleQualification• B.Pharm (Bachelor of Pharmacy) / M.Pharm (Master of Pharmacy) / Life Sciences / Clinical Research or equivalent (preferred)Experience• Minimum 3+ years of experience in Clinical Data Management• Hands-on experience with Medidata RAVE EDC• Experience in UAT testing and database validation• Exposure to study conduct phase and database lock activities• Experience coordinating with sponsors and cross-functional teamsSkills• Strong query management and discrepancy handling expertise• Knowledge of data validation checks and edit check review• Understanding of clinical trial lifecycle and CDM processes• Familiarity with database freeze and lock procedures• Strong analytical and problem-solving skills• Effective stakeholder communication and coordinationWalk-In Interview DetailsDate: 23rd FebruaryTime: 10:30 AM – 2:00 PMVenue: Jubilee Hills Check Post Rd, Jawahar Colony, Jubilee Hills, Hyderabad, Telangana 500033About the OrganizationOrciMed is a clinical research organization delivering data management and clinical operations services for global trials. The company focuses on regulatory compliance, data integrity, and efficient clinical database lifecycle management to support international pharmaceutical and biotech sponsors.

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• Monitor and oversee clinical trials at investigational sites• Conduct site initiation, routine monitoring, and close-out visits• Ensure compliance with study protocols, ICH-GCP, and regulatory guidelines• Track clinical operations timelines and study progress• Verify source documents and ensure data accuracy and integrity• Prepare monitoring visit reports and maintain essential trial documentation• Coordinate with investigators, site staff, and internal cross-functional teams• Ensure proper maintenance of Trial Master File (TMF) documents• Identify protocol deviations and support corrective and preventive actions (CAPA)• Support audit and inspection readiness activitiesQualification• Bachelor’s Degree in Life Sciences, Pharmacy, or related fieldExperience• Prior experience in clinical research industry (preferred but not mandatory)• Understanding of clinical trial processes and clinical operations• Exposure to regulatory requirements and compliance standardsSkills• Strong knowledge of ICH-GCP guidelines• Attention to detail and high documentation accuracy• Good organizational and time management skills• Effective communication and stakeholder coordination• Ability to work independently and on-siteAbout the OrganizationEccentric Clinical Research (ECR) is a comprehensive clinical research service provider supporting pharmaceutical, nutraceutical, cosmetic, herbal, and medical device companies. The organization delivers customized research solutions while maintaining high regulatory, ethical, and quality standards across clinical development projects.

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• Coordinate day-to-day clinical trial activities at the study site• Assist investigators in patient screening, recruitment, and follow-up visits• Maintain and update Trial Master File (TMF) and essential study documents• Ensure compliance with ICH-GCP guidelines and approved study protocols• Support and document the informed consent process• Perform data entry and resolve queries in CRF/eCRF systems• Communicate with sponsors, CROs, and ethics committees• Prepare study reports and maintain regulatory documentation• Support monitoring visits and auditsQualification• B.Sc / M.Sc or equivalent degree in Life Sciences• Master of PharmacyExperience• Minimum 1 year of clinical research experience• Experience in site coordination and clinical trial documentation preferredSkills• Understanding of clinical trial processes• Basic knowledge of ICH-GCP guidelines• Strong documentation skills• Proficiency in CRF/eCRF systems• Good communication and coordination abilities• Attention to detail and compliance awarenessAbout the OrganizationA leading clinical research services provider based in Delhi, India, offering structured clinical trial management solutions. The organization provides strong exposure to clinical operations, regulatory documentation, and sponsor coordination within a professional research environment.

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.

Roles & Responsibilities• Lead a portfolio of clinical studies/programs with end-to-end functional, administrative, and financial oversight from start-up through close-out• Act as the primary liaison between clients, project teams, and cross-functional stakeholders for all data management activities• Coach, mentor, and direct CDM staff to ensure accurate, on-time, and within-budget delivery meeting client expectations• Perform independent reviews of CDM deliverables and ensure adherence to CDM guidelines, global SOPs, and regulatory requirements• Develop and deliver study-specific training for DM project staff as needed• Forecast hours, plan resourcing, and manage budgets including identification of out-of-scope work and support contract modification processes• Monitor project risks to deliverables and finances, propose mitigation strategies, and drive timely issue resolution• Lead and delegate tasks across the study team to achieve timelines, quality, scope, and budget commitments• Drive process improvements and support development/implementation of CDM processes, procedures, and training initiatives• Support business development through bid preparation, representation at bid defense meetings, and relationship building for repeat business• Ensure inspection-ready outcomes by maintaining high-quality data delivery standards across the portfolioQualification• Bachelor’s degree or equivalent in a relevant disciplineExperience• 6 to 8 years of relevant Clinical Data Management experience• Hands-on experience with RAVE / Veeva EDC requiredSkills• Portfolio/study leadership and stakeholder management with strong client-facing communication• CDM project planning, timeline ownership, resource forecasting, and budget management• Risk identification, impact assessment, and mitigation planning for deliverables and finances• Strong knowledge of regulatory guidelines and global SOPs for clinical data management• Strong analytical/problem-solving skills with excellent written and verbal communication and English grammar• Ability to train, supervise, and delegate effectively across teams (subordinates and peers)• High confidentiality and sound judgement in handling clinical and proprietary data• Strong proficiency with interactive clinical systems and tools, including EDC platforms• Ability to act as a subject matter expert for DM processes and drive continuous improvementAbout The CompanyThermo Fisher Scientific, through its PPD clinical research services portfolio, delivers global clinical research and data management solutions for leading pharmaceutical and biotech clients. With a mission to make the world healthier, cleaner, and safer, Thermo Fisher supports clinical trials at scale through mature FSP delivery models, global collaboration, and technology-enabled, inspection-ready execution.

Role & Responsibilities• Manage end-to-end eTMF/TMF activities to support clinical trial operations and ensure inspection readiness• Oversee collection, review, indexing, filing, and quality control of clinical trial documents within the eTMF system• Ensure TMF completeness, accuracy, and timeliness in line with ICH-GCP and applicable regulatory guidance• Perform periodic TMF quality checks, reconcile missing/expired documents, and drive follow-ups with stakeholders/vendors• Coordinate with Clinical Operations, CROs, sites, and functional teams to ensure correct document workflows and version control• Prepare TMF status/metrics reports and support audits/inspections by providing requested documentation and evidence• Support process improvements, SOP adherence, and training/guidance to team members on TMF practicesQualification• Bachelor’s degree in Life Sciences, Healthcare, Pharmacy, or related fieldExperience• 7 years of relevant experience in Clinical Operations and/or Clinical Document Management (eTMF preferred)Skills• Strong working knowledge of clinical research documents and TMF lifecycle management• Knowledge of ICH-GCP and regulatory guidance for trial documentation• Excellent verbal and written communication skills• eTMF operations, document QC, reconciliation, and inspection readiness mindset• Proficiency in Microsoft Office (Word, Excel, etc)About The CompanyVARITE INC is a staffing and talent solutions organization supporting clients with contract and full-time hiring across multiple domains. This role is a full-time on-site opportunity in Bengaluru (Manyata Tech Park) with compensation up to 15 LPA and a face-to-face interview process scheduled for the last week of February.

Roles & Responsibilities• Support coordination of clinical trial activities at the site level under guidance of seniors and investigators• Assist in study start-up activities including essential document collection and site file setup• Maintain and update Trial Master File (TMF) / Investigator Site File (ISF) documentation as per protocol and SOPs• Help schedule and coordinate subject visits, follow-ups, and study-related appointments• Support informed consent process coordination and ensure documents are filed correctly (as per site practice)• Assist in source document review, data entry support, and query follow-up with relevant teams• Coordinate communication between investigators, study team, sponsor/CRO, and other stakeholders• Support monitoring visit readiness by ensuring documents and logs are updated and available• Track study supplies, lab sample coordination, and shipment documentation where applicable• Ensure compliance with GCP, protocol requirements, and internal quality processesQualification• Graduate/Postgraduate in Life Sciences, Pharmacy, Biotechnology, Microbiology, Nursing, or related disciplineExperience• Fresher / Entry-level candidates eligible• Basic understanding of clinical research and GCP preferredSkills• Basic knowledge of clinical research processes and documentation (TMF/ISF)• Good communication and coordination skills• Attention to detail and strong documentation discipline• Basic computer skills and MS Office proficiency• Ability to learn quickly and work in a regulated environmentAbout The CompanyClinoGenesis Research Institute provides training and career opportunities in clinical research, supporting entry-level roles and skill development for candidates looking to start their careers in clinical trials and related healthcare research domains.

Roles & Responsibilities• Conduct Site Selection Visits (SSV), Site Initiation Visits (SIV), Interim Monitoring Visits (IMV), and Close-Out Visits (COV)• Ensure clinical trials are conducted in compliance with ICH-GCP guidelines, SOPs, and applicable regulatory requirements• Monitor study progress to ensure adherence to approved protocol, timelines, and quality standards• Perform Source Data Verification (SDV) and validate CRF/eCRF entries for accuracy and completeness• Identify, document, and follow up on protocol deviations, discrepancies, and corrective actions• Maintain, review, and update Trial Master File (TMF) documentation• Ensure proper informed consent process compliance and documentation• Coordinate with investigators, site staff, CROs, and sponsors for smooth study execution• Track, review, and report Serious Adverse Events (SAEs) as per regulatory timelines• Prepare detailed monitoring visit reports and follow-up letters• Support audit and inspection readiness by ensuring documentation accuracy and completeness• Assist in regulatory submissions and essential document managementQualification• B.Pharm (Bachelor of Pharmacy) / M.Pharm (Master of Pharmacy)• BSc / MSc in Life Sciences, Clinical Research, or related disciplineExperience• 1–2 years of hands-on experience in clinical trial monitoring• Working knowledge of ICH-GCP guidelines• Experience in TMF maintenance and SAE reportingSkills• Strong clinical trial monitoring expertise• Proficiency in Source Data Verification (SDV)• Experience with eCRF documentation and review• Strong understanding of regulatory compliance frameworks• Excellent documentation and reporting skills• Strong communication and site coordination abilities• Ability to manage multiple study activities efficiently• High attention to detail and quality-focused approachAbout the OrganizationDesun Hospital is a multi-specialty healthcare institution in Kolkata with a structured clinical research environment. The hospital provides opportunities for clinical research professionals to gain hands-on experience in monitoring, regulatory compliance, and investigator coordination within a hospital-based research setup.

Roles & Responsibilities• Conduct site monitoring visits to ensure compliance with study protocol, ICH-GCP, regulatory requirements, and company SOPs• Oversee Phase IV, PMS, and RWE studies to ensure data integrity, subject safety, and protocol adherence• Perform site qualification, initiation, routine monitoring, and close-out visits as required• Assess site performance, enrollment progress, and data quality; implement corrective actions when necessary• Ensure timely and accurate source data verification (SDV) and query resolution• Maintain inspection-ready documentation including essential documents and monitoring reports• Collaborate with cross-functional teams including medical, safety, data management, and regulatory teams• Provide training and ongoing guidance to site staff and junior CRAs• Support vendor oversight and coordination with CRO partners where applicable• Identify risks proactively and escalate issues to study leadership with mitigation strategies• Ensure proper documentation, tracking, and reporting of study milestones and deliverables• Independently manage multiple studies while meeting tight timelinesQualification• Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, or related field• Advanced clinical research certification (preferred)• Master of Pharmacy (M.Pharm)Experience• 5+ years of overall experience in clinical research• 2–3 years of CRA/monitoring experience in Phase II–IV trials• Prior hands-on experience in PMS, RWE, or post-marketing studies is essential• Experience working with CROs, external vendors, and cross-functional medical teamsSkills• Strong knowledge of ICH-GCP, regulatory guidelines, and clinical trial conduct• Excellent monitoring, documentation, and administrative skills• Strong stakeholder management and communication abilities• Ability to independently manage multiple concurrent studies• High attention to detail and quality compliance mindset• Strong problem-solving and risk management skills• Proficiency in CTMS, EDC, and clinical trial systems• Effective coordination and cross-functional collaboration skillsAbout the OrganizationICON plc is a global healthcare intelligence and clinical research organization supporting pharmaceutical, biotechnology, and medical device companies in clinical development. ICON is committed to operational excellence, innovation, and building a diverse culture that rewards high performance while promoting well-being and work-life balance.