Clinical Research Jobs in Chennai

Why This Role MattersThe Manager – Clinical Database Management plays a strategic role within Clinical Data Sciences (CDS), ensuring high-quality clinical database design, development, and lifecycle management across assigned studies and therapy areas. In modern drug development, reliable and standardized clinical data systems are essential for regulatory submissions, safety reporting, and data-driven decision-making.This role ensures operational excellence in database build, change control, and data capture technologies while maintaining strict compliance with regulatory standards and internal SOPs. By leading database management initiatives and collaborating closely with Clinical Data Scientists, the position directly contributes to data integrity, submission readiness, and portfolio success.At Pfizer, Clinical Data Sciences professionals play a key role in accelerating innovation through structured, compliant, and technology-driven clinical data management.Job DescriptionThe Manager – Clinical Database Management is responsible for providing project management leadership and technical expertise in clinical database design and maintenance within the Clinical Development & Operations organization.The role oversees the database development cycle, ensures effective change control management, and maintains integrity and consistency of clinical data aligned with Pfizer standards. The candidate will serve as a Subject Matter Expert (SME) for database build activities within assigned therapy areas and ensure seamless collaboration between Database Management (DBM) and Clinical Data Scientist functions.This is a hybrid work location assignment within a global, cross-functional clinical operations environment.Key Features of the Role:• Position: Manager – Clinical Database Management• Department: Clinical Data Sciences (CDS)• Experience Required: Minimum 10 years in clinical data/project management• Industry: Pharmaceutical / Biotech / CRO / Regulatory• Focus: Clinical database design, development, and lifecycle management• Expertise in EDC systems and clinical data platforms• Hybrid work model• Leadership and mentoring responsibilitiesResponsibilities• Manage the development cycle of data capture solutions supporting study data review plans• Oversee database build, implementation, and change control processes• Ensure integrity, quality, and compliance of clinical databases• Serve as project management resource to study teams for database development planning• Identify risks proactively and develop mitigation strategies• Perform impact analysis for proposed tool/process changes• Solve moderately complex database build and implementation challenges• Lead operational activities supporting short-term departmental goals• Represent Database Management in Clinical Data Sciences initiatives• Ensure compliance with SOPs and work practices• Collaborate with Clinical Data Scientists to ensure seamless CDS deliverables• Support standardization and consistency across asset/submission data• Assess change control impacts and implement mitigation plans• Drive process improvements and innovative solutions• Mentor junior staff members when required• Participate in Pfizer Standards meetings and cross-functional governance forumsRequired QualificationsCandidates must demonstrate strong expertise in clinical database management, project leadership, and regulatory data standards.Educational Requirements:• Bachelor’s degree in Life Sciences, Computer Science, or equivalent (Mandatory)Experience and Skills:• Minimum 10 years of project management experience in pharmaceutical, biotech, CRO, or regulatory settings• Strong experience in building data collection and assimilation solutions• Proficiency in Electronic Data Capture (EDC) systems• Experience with Clinical Data Management Systems such as Oracle InForm, Data Management Workbench• Familiarity with relational databases (MS SQL Server, MS Access)• Experience with data visualization tools such as Spotfire and J-Review• Hands-on experience with MS Project or enterprise project management tools• Strong communication, influencing, negotiation, and decision-making skills• Understanding of drug development processes and clinical data operations• Knowledge of regulatory requirements and CDISC standards (preferred)• Proficiency in Microsoft Office SuiteSalary InsightsCompensation will be competitive and aligned with senior-level clinical data management roles within global pharmaceutical organizations. Salary may vary depending on experience in database technologies, regulatory standards, and leadership responsibilities. Additional benefits and hybrid flexibility are provided as per company policy.Company OverviewPfizer is a global biopharmaceutical leader committed to discovering and delivering innovative medicines and vaccines. The Clinical Data Sciences group is an integral part of the Clinical Development & Operations organization, supporting high-quality clinical data solutions that drive regulatory approvals and patient safety worldwide.Pfizer promotes diversity, innovation, operational excellence, and compliance while offering professionals opportunities to grow within a global healthcare environment.FAQsQ1. Is prior clinical database management experience mandatory?Yes, extensive experience in clinical database build and project management is required.Q2. Is knowledge of EDC systems necessary?Yes, familiarity with Oracle InForm or similar systems is essential.Q3. Does the role involve leadership responsibilities?Yes, the role includes leading initiatives and mentoring junior team members.Q4. Is CDISC knowledge required?It is preferred but not mandatory.Q5. Is this a remote role?No, this is a hybrid work model position.Application Tip• Highlight experience with Oracle InForm or similar EDC platforms• Mention global clinical trial database management exposure• Showcase project management tools and methodologies used• Demonstrate knowledge of CDISC and regulatory submission standards• Provide examples of risk mitigation and change control management• Emphasize leadership and cross-functional collaboration experience

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

Why This Role MattersClinical research plays a critical role in advancing medical innovation, improving patient outcomes, and bringing new therapies to market. As a global healthcare intelligence and clinical research organization, ICON plc contributes to shaping the future of clinical development through data-driven insights and scientific excellence.This internship provides emerging life science professionals with hands-on exposure to real-world research operations, project workflows, and healthcare intelligence systems. By supporting ongoing initiatives and collaborating with experienced teams, interns gain practical knowledge that bridges academic learning with industry application.For candidates seeking a career in clinical research, pharmaceuticals, biotechnology, or healthcare analytics, this opportunity offers a strong professional foundation within a globally recognized organization.Job DescriptionICON plc is seeking a motivated Intern to join its Chennai office-based team. This role offers structured exposure to research processes, project coordination, and administrative operations within a professional corporate environment.As an Intern, you will assist team members in research, data management, documentation preparation, and workflow coordination. You will participate in meetings, contribute ideas, and support projects aligned with ICON’s mission to deliver innovative clinical development solutions.The internship emphasizes skill development, teamwork, and professional growth while contributing meaningfully to organizational objectives.Key Features of the Role• Office-based internship in Chennai• Exposure to clinical research and healthcare intelligence• Hands-on project experience• Professional development and networking opportunities• Collaborative and inclusive work culture• Competitive internship compensation• Global organization with structured learning environmentResponsibilities• Assist with research activities, data collection, and preliminary analysis• Support preparation of reports, presentations, and documentation• Participate in team meetings and contribute to discussions• Help coordinate project-related administrative tasks• Maintain organized records and ensure data accuracy• Support day-to-day operational tasks to enhance workflow efficiency• Engage in training and development sessions• Collaborate with cross-functional teams when requiredRequired Qualifications• Bachelor’s or Master’s degree in a Life Sciences discipline• Strong academic background in biological, pharmaceutical, or healthcare sciences• Proficiency in Microsoft Office applications• Eligibility to work in IndiaEducational Requirements• Completed or currently pursuing Bachelor’s or Master’s degree in Life Sciences (e.g., Biotechnology, Pharmacy, Microbiology, Biochemistry, Clinical Research)• Academic understanding of research methodologies and data handlingExperience and Skills• Strong interest in clinical research and healthcare intelligence• Excellent organizational and time-management skills• Ability to manage multiple tasks and deadlines• Strong written and verbal communication skills• Analytical thinking and attention to detail• Familiarity with data analysis or project management tools (advantageous)• Ability to work independently and collaboratively• Willingness to learn and adapt in a professional environmentSalary InsightsICON plc offers competitive internship compensation aligned with industry standards in India. In addition to salary, interns may benefit from:• Exposure to global clinical research operations• Structured professional development• Networking opportunities with industry professionals• Access to employee support resources• Potential pathways for future employment within the organizationCompany OverviewICON plc is a world-leading healthcare intelligence and clinical research organization providing outsourced development and commercialization services to pharmaceutical, biotechnology, and medical device companies.The company fosters an inclusive culture focused on innovation, operational excellence, and employee development. With a global presence, ICON supports clinical trials and research initiatives that drive advancements in medicine and patient care worldwide.Employee BenefitsICON offers a comprehensive and competitive benefits package designed to promote well-being and work-life balance. Examples include:• Annual leave entitlements• Health insurance options• Retirement planning programs• Life assurance coverage• Access to Global Employee Assistance Programme (LifeWorks)• Flexible country-specific optional benefits such as childcare vouchers, gym membership discounts, travel pass subsidies, and health assessmentsBenefits may vary based on country and employment status.FAQsQ: Is this an office-based role?Yes, this internship is office-based in Chennai.Q: Is prior clinical research experience required?No prior experience is mandatory, but a strong interest in research is expected.Q: What qualifications are required?A Bachelor’s or Master’s degree in a Life Sciences discipline.Q: Are there opportunities for future employment?High-performing interns may have opportunities to explore future roles within ICON, subject to availability.Application Tips• Highlight academic projects related to research or data analysis• Emphasize proficiency in Microsoft Office and analytical tools• Demonstrate strong organizational and communication skills• Mention internships, coursework, or certifications relevant to clinical research• Showcase enthusiasm for learning and contributing in a professional environment

Why This Role MattersThe Regulatory Associate plays a crucial role in ensuring that all regulatory submissions are prepared, formatted, and delivered accurately and on time. By managing publishing, dispatching, and archiving of submissions in compliance with agency standards, the Regulatory Associate supports the organization’s commitment to regulatory compliance and timely product approvals. This role ensures high-quality submissions, enabling smooth interactions with regulatory authorities and contributing to successful drug development and market access.Job DescriptionThe Regulatory Associate is responsible for publishing, formatting, and dispatching regulatory submissions in agency-recommended formats. The role involves collaborating with cross-functional teams, performing quality control checks, troubleshooting technical issues in document preparation, and ensuring timely delivery of submissions. The Regulatory Associate also maintains knowledge of agency standards, manages technical aspects of submissions, and ensures that documents meet client and internal requirements for regulatory compliance.Key Features Of The Role• Publish, dispatch, and archive regulatory submissions in agency-recommended formats• Ensure timely delivery of high-quality submissions following internal processes and client requirements• Prepare submission-ready documents for electronic submissions, including formatting, hyperlinking, and processing in MS Word and Adobe Acrobat• Develop and maintain up-to-date knowledge of established agency standards and procedures for regulatory submissions• Troubleshoot document issues with Adobe Acrobat and MS Word• Manage technical aspects and status updates for assigned submissions• Collaborate with various departments for planning, preparation, publishing, and quality control checks of submissions• Maintain compliance with internal SOPs and regulatory guidelines• Support improvements in document preparation processes and publishing workflowsResponsibilities• Prepare and format regulatory documents for electronic submissions according to agency standards• Perform quality checks on submission documents to ensure accuracy, completeness, and compliance• Troubleshoot and resolve technical issues related to document formatting, hyperlinks, and PDFs• Track submission status and provide updates to internal stakeholders• Maintain submission archives and records for easy retrieval and audit readiness• Collaborate with regulatory, clinical, and quality teams to ensure coordinated preparation of submissions• Support the implementation of publishing tools, validation software, and new processes• Keep up-to-date with changes in regulatory guidelines and publishing standards• Assist in training junior staff on submission formatting, publishing, and quality control practicesRequired QualificationsEducational Requirements• Bachelor’s Degree in Pharmacy or related fieldExperience And Skills• Prior experience in regulatory publishing and submissions• Proficiency in MS Word and Adobe Acrobat for document preparation and formatting• Familiarity with electronic submission requirements and validation tools• Knowledge of agency standards and regulatory submission processes• Strong attention to detail and commitment to accuracy• Good communication skills and ability to collaborate with cross-functional teams• Ability to troubleshoot technical issues in submission documentsSalary Insights• Compensation as per company norms and industry standards• Performance-based incentives and opportunities for career growth• Exposure to regulatory submission processes and electronic publishing toolsCompany OverviewThe organization is a global clinical research and pharmaceutical services provider, committed to delivering high-quality regulatory, clinical, and drug development solutions. The company emphasizes professional growth, collaborative teamwork, and adherence to regulatory compliance standards to ensure successful project outcomes and timely submissions.FAQsQ: What type of submissions will I work on?A: The Regulatory Associate will handle regulatory submissions in agency-recommended electronic formats, including formatted documents, PDFs, and hyperlinks.Q: Will I need technical skills?A: Yes, proficiency in MS Word, Adobe Acrobat, and familiarity with publishing and validation tools is required.Q: Is prior experience in regulatory publishing mandatory?A: Yes, prior experience in publishing and regulatory submissions is required.Application Tips• Highlight prior experience in regulatory publishing and electronic submissions• Showcase proficiency in MS Word, Adobe Acrobat, and validation tools• Demonstrate attention to detail and knowledge of agency submission standards• Emphasize ability to collaborate with cross-functional teams and meet deadlines

Why This Role MattersAccurate and complete documentation is the backbone of every successful clinical trial. Regulatory authorities require sponsors and CROs to maintain a well-organized Trial Master File (TMF) that demonstrates compliance with Good Clinical Practice (GCP), protocol adherence, and participant safety. Even minor documentation gaps can lead to inspection findings, compliance risks, or delays in regulatory approvals.The TMF Specialist I plays a foundational role in maintaining documentation quality and ensuring inspection readiness. At ICON plc, this position supports global clinical studies by contributing to document management activities, maintaining organized TMF structures, and ensuring adherence to both client and internal requirements. This role is ideal for professionals looking to strengthen their expertise in clinical documentation while building a long-term career in clinical research operations.Job DescriptionThe TMF Specialist I is responsible for supporting Trial Master File management activities across assigned projects. This role focuses on gaining familiarity with TMF structures, essential document requirements, document indexing, and compliance processes.Working closely with cross-functional teams, the TMF Specialist I assists in maintaining accurate and complete documentation within electronic document management systems. The role ensures that documentation activities align with client contracts, regulatory standards, and ICON procedures.This position requires strong attention to detail, organizational discipline, and a willingness to learn regulatory frameworks and documentation standards within a dynamic clinical research environment.Key Features of the Role• Entry-to-mid level opportunity within TMF Operations• Exposure to global clinical trial documentation processes• Hands-on experience with electronic document management systems• Cross-functional collaboration with Clinical Operations teams• Strong learning and development pathway• Foundation for career growth into TMF Specialist II, Senior TMF Specialist, or Clinical Operations roles• Compliance-focused and quality-driven environmentResponsibilities• Gain familiarity with Trial Master File (TMF) structure and essential document categories.• Assist in organizing, filing, and maintaining TMF documentation in electronic systems.• Ensure documents are uploaded, indexed, and classified correctly according to internal SOPs and client requirements.• Support ongoing document reconciliation and tracking activities.• Contribute to client services contracts and internal business requirements related to TMF management.• Verify document completeness and accuracy prior to filing.• Maintain audit-ready documentation standards under supervision.• Collaborate with Clinical Trial Managers, CRAs, and Regulatory teams to obtain required documents.• Follow established workflows for document review and approval processes.• Support quality checks to ensure compliance with ICH-GCP guidelines.• Assist in responding to internal queries related to document location and filing status.• Contribute to continuous improvement initiatives within TMF processes.Required Qualifications• Understanding or willingness to learn Trial Master File documentation standards.• Basic knowledge of clinical research processes preferred.• Strong organizational and document management skills.• High attention to detail and accuracy.• Ability to work within structured SOP-driven environments.• Effective communication skills for cross-team collaboration.• Ability to manage assigned tasks within defined timelines.Educational Requirements• Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, Nursing, or a related scientific discipline.• Additional certification in Clinical Research or Regulatory Affairs is an advantage but not mandatory.Experience and Skills• 3+ years of prior experience in clinical research, document management, or related roles preferred.• Familiarity with electronic document management systems (eTMF systems preferred).• Basic understanding of ICH-GCP guidelines and regulatory documentation standards.• Experience supporting cross-functional teams in documentation activities.• Strong proficiency in Microsoft Office tools.• Ability to prioritize tasks and manage workload effectively.• Strong written and verbal communication skills.• Demonstrated ability to work effectively within a team environment.Salary InsightsCompensation for the TMF Specialist I role is competitive and aligned with entry-to-mid level clinical documentation positions within global CROs. Salary may vary depending on experience, skillset, and geographic location.In addition to base salary, employees at ICON plc may receive:• Health insurance coverage for employees and families• Retirement savings programs• Annual leave entitlements• Life assurance benefits• Global Employee Assistance Programme (LifeWorks)• Flexible country-specific optional benefits such as wellness initiatives and lifestyle programsICON’s total rewards structure is designed to support professional growth, financial security, and work-life balance.Company OverviewICON plc is a globally recognized healthcare intelligence and clinical research organization that partners with pharmaceutical, biotechnology, and medical device companies to accelerate the development of innovative therapies.Operating across multiple continents, ICON provides comprehensive clinical development services spanning early-phase trials through post-marketing research. The company emphasizes operational excellence, regulatory compliance, and scientific innovation.ICON fosters a diverse and inclusive workplace culture, committed to equal opportunity employment and accessible work environments. Professional development, collaboration, and continuous learning are central to the organization’s values.FAQs1. Is prior TMF experience mandatory?While prior TMF or document management experience is preferred, candidates with clinical research exposure and strong documentation skills are encouraged to apply.2. Is this role suitable for freshers?The role prefers candidates with some prior experience (3+ years), but relevant internships or document management exposure may be considered.3. Does this role involve regulatory inspections?The role supports inspection readiness activities but does not independently lead inspections at this level.4. What growth opportunities are available?Progression may include TMF Specialist II, Senior TMF Specialist, or broader Clinical Operations roles.5. Is system experience required?Familiarity with electronic document management systems is beneficial but can be developed on the job.Application Tips• Highlight any TMF, eTMF, or document management experience clearly.• Demonstrate understanding of GCP and regulatory documentation standards.• Showcase examples of accuracy and attention to detail in previous roles.• Mention experience working with cross-functional teams.• Emphasize organizational skills and ability to meet timelines.• Quantify experience where possible (number of studies supported, documents handled, etc.).

Why This Role MattersIn clinical research, documentation is the foundation of regulatory compliance and patient safety. Every clinical trial must maintain a complete and accurate Trial Master File (TMF) to demonstrate that the study was conducted in accordance with ICH-GCP guidelines and global regulatory requirements. Inspection readiness is not a one-time milestone it is a continuous process.At ICON plc, the Senior TMF Specialist plays a critical role in ensuring that essential documents are complete, properly indexed, and audit-ready throughout the study lifecycle. This role directly supports regulatory inspections, quality oversight, and operational excellence, contributing to the timely development of innovative therapies worldwide.Job DescriptionThe Senior TMF Specialist is responsible for overseeing electronic Trial Master File (eTMF) activities across assigned clinical studies. The position focuses on completeness reviews, missing document identification, metadata verification, and compliance monitoring within Veeva Vault.The role requires strong expertise in TMF structure, essential document requirements, and regulatory standards. The candidate must be detail-oriented, proactive in risk identification, and capable of managing multiple studies while adhering to agreed service level agreements (SLAs).Key Features of the RoleGlobal clinical trial exposureInspection readiness responsibilityAdvanced eTMF system involvement (Veeva Vault)Cross-functional collaboration with study teamsCompliance-driven and quality-focused environmentOpportunity for mentoring and training supportCareer progression into TMF Lead or Clinical Operations rolesResponsibilities• Perform comprehensive periodic and milestone-based eTMF completeness reviews.• Conduct cross-checks and co-dependency checks to ensure document alignment.• Identify missing, misfiled, or incomplete documents within Veeva Vault.• Maintain and update the Expected Document List (EDL) as required.• Ensure assigned studies remain inspection-ready at all times.• Apply ALCOEA principles to ensure documentation integrity and traceability.• Verify metadata accuracy and proper indexing within the system.• Ensure compliance with ICH-GCP guidelines and global regulatory requirements.• Support internal audits and regulatory inspections.• Proactively track overdue documents and escalate risks where necessary.• Collaborate with study teams to collect pending documents.• Monitor action items and ensure timely resolution within SLAs.• Maintain documentation tracking logs and review reports.• Provide training and guidance to internal teams on TMF best practices.• Participate in review meetings and communicate documentation gaps clearly.• Contribute to process improvements to enhance TMF efficiency and quality.Required Qualifications• Strong knowledge of Trial Master File structure and essential documents.• In-depth understanding of ICH-GCP and global regulatory standards.• Hands-on experience with electronic TMF systems (Veeva Vault preferred).• Excellent organizational and analytical skills.• Strong communication and stakeholder management abilities.• Ability to manage multiple clinical studies simultaneously.• High attention to detail and quality-focused mindset.Educational Requirements• Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, or related scientific field.• Advanced degree preferred but not mandatory.• Clinical research or regulatory certifications are an added advantage.Experience and Skills• Minimum 7 years of TMF management experience.• 2–3 years of experience in missing document identification and resolution.• Experience conducting periodic and milestone-based TMF reviews.• Strong working knowledge of Veeva Vault eTMF system.• Proficiency in Microsoft Excel and document tracking tools.• Experience supporting inspection readiness initiatives.• Ability to interpret regulatory guidance and apply to documentation processes.• Proven track record of meeting SLAs and maintaining quality standards.Salary InsightsCompensation is competitive and aligned with industry benchmarks for senior-level TMF roles within global CROs. Salary varies based on experience, technical expertise, and geographic location.Benefits may include:• Comprehensive health insurance• Retirement planning programs• Performance-based incentives• Annual leave entitlements• Employee assistance programs• Flexible benefit optionsAt ICON plc, total rewards are designed to support professional growth, financial security, and work-life balance.Company OverviewICON plc is a leading healthcare intelligence and clinical research organization supporting pharmaceutical, biotechnology, and medical device companies worldwide. The organization operates across multiple continents, delivering clinical development services that accelerate the availability of life-changing treatments.ICON fosters an inclusive and high-performance culture, encouraging collaboration, innovation, and continuous learning. Employees benefit from global exposure, structured career growth pathways, and a strong commitment to diversity and equal opportunity.FAQsIs Veeva Vault experience mandatory?It is highly preferred and considered a strong advantage.Does the role involve regulatory submissions?The focus is on TMF oversight rather than direct regulatory submissions.Is inspection readiness a key responsibility?Yes, ensuring inspection readiness is a core function of the role.What growth opportunities are available?Potential progression includes TMF Lead, Clinical Operations, or Quality Assurance roles.Application Tips• Clearly highlight TMF review and missing document identification experience.• Mention hands-on experience with Veeva Vault and eTMF systems.• Demonstrate knowledge of ALCOEA principles and ICH-GCP guidelines.• Quantify experience (number of studies supported, audits handled, etc.).• Showcase examples of stakeholder collaboration and SLA management.

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.