Senior TMF Specialist Job in Chennai at ICON plc with 7 years TMF experience and Veeva Vault expertise. Apply online today.
Experienced clinical research professionals looking to advance their career in Trial Master File (TMF) management have a promising opportunity in Chennai. A leading global CRO is inviting applications for a Senior TMF Specialist role focused on regulatory compliance, document quality, and inspection readiness. This position is ideal for candidates with strong expertise in eTMF systems and clinical trial documentation oversight.
Company Overview
ICON plc is a globally recognized Contract Research Organization (CRO) that delivers healthcare intelligence and clinical development solutions to pharmaceutical, biotechnology, and medical device companies. With operations across multiple countries, ICON supports innovative drug development programs from early-phase research to post-marketing studies. The organization is known for its commitment to quality standards, regulatory compliance, and fostering professional growth in the clinical research industry. Senior TMF Specialist Job in Chennai at ICON plc
Job Location & Employment Type
- Location: Chennai, Tamil Nadu, India
- Work Model: Office with Flexibility
- Employment Type: Full-Time
- Job Requisition ID: JR142071
This role offers a hybrid working structure, allowing professionals to balance on-site collaboration with flexible arrangements as per company policy. Senior TMF Specialist Job in Chennai at ICON plc
Department & Position Details
- Department: Clinical Trial Documentation / TMF Operations
- Position: Senior TMF Specialist
- Experience Level: Senior-Level Professional
The selected candidate will be responsible for overseeing Trial Master File management activities across assigned clinical studies, ensuring inspection readiness and adherence to global regulatory requirements. Senior TMF Specialist Job in Chennai at ICON plc
Key Roles & Responsibilities
As a Senior TMF Specialist, the primary responsibility will be to ensure completeness, accuracy, and compliance of Trial Master Files in electronic systems. Key responsibilities include:
- Conduct comprehensive periodic and milestone-based eTMF reviews.
- Perform cross-checks and co-dependency assessments to identify gaps or missing documents.
- Manage and review documentation within Veeva Vault or similar electronic document management systems.
- Ensure that assigned studies remain inspection-ready at all times.
- Update and maintain the Expected Document List (EDL) in alignment with protocol and regulatory requirements.
- Identify and resolve documentation discrepancies in coordination with study teams.
- Perform ALCOEA (Attributable, Legible, Contemporaneous, Original, Accurate, and Complete) checks and metadata validation.
- Collaborate closely with TMF Leads and cross-functional teams to collect documentation requirements.
- Follow up with stakeholders to close open action items within defined timelines.
- Deliver internal training sessions to team members on TMF best practices.
- Adhere to defined Service Level Agreements (SLAs) and ensure deliverables meet stakeholder expectations.
- Maintain compliance with ICH-GCP guidelines and other applicable regulatory frameworks.
This role requires strong attention to detail, proactive communication, and the ability to manage multiple studies simultaneously. Senior TMF Specialist Job in Chennai at ICON plc
Eligibility Criteria
Educational Qualification
- Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, or related scientific discipline.
- Advanced degrees such as M.Pharm, M.Sc, or related postgraduate qualifications will be considered advantageous.
Experience Requirements
- Minimum 7 years of hands-on experience in TMF management and periodic review processes.
- At least 2–3 years of direct experience in identifying and managing missing TMF documents.
- Prior exposure to global clinical trials and regulatory inspections is preferred.
Required Skills
- Strong understanding of TMF regulations, ICH-GCP guidelines, and compliance standards.
- Working knowledge of electronic TMF systems, especially Veeva Vault.
- Proficiency in Microsoft Excel and document tracking tools.
- Excellent documentation review and audit-readiness capabilities.
- Strong analytical skills to identify document gaps and inconsistencies.
- Effective communication skills for coordination with cross-functional teams.
- High level of organizational skills and ability to manage deadlines.
Candidates with experience in global CRO environments and multi-study oversight will have an added advantage. Senior TMF Specialist Job in Chennai at ICON plc
Salary & Benefits
Compensation for this role will be offered as per company norms and based on experience and qualifications.
In addition to salary, the organization offers a range of employee-focused benefits, which may include:
- Paid annual leave as per company policy
- Health insurance coverage for employees and eligible dependents
- Retirement and long-term financial planning benefits
- Employee Assistance Program for mental health and well-being
- Life insurance coverage
- Flexible benefit options depending on regional policies
Benefits are structured to support work-life balance and long-term career development. Senior TMF Specialist Job in Chennai at ICON plc
Selection Process
The recruitment process may include:
- Application screening based on eligibility and experience.
- Technical and functional interview rounds.
- HR discussion covering compensation and company policies.
- Final selection and offer release.
Only shortlisted candidates will be contacted for further rounds. Senior TMF Specialist Job in Chennai at ICON plc
How to Apply
Interested candidates should apply through the official company careers portal using the job requisition ID JR142071. Applicants are advised to ensure that their CV highlights relevant TMF experience, system knowledge, and regulatory expertise.
Early application is recommended as positions may close once suitable candidates are identified. Senior TMF Specialist Job in Chennai at ICON plc
Important Dates
- Application Deadline: Not specified (Apply at the earliest)
Why Apply for This Pharma Job?
- Opportunity to work with a globally established CRO.
- Exposure to international clinical trial documentation standards.
- Career progression in advanced TMF and compliance management.
- Hybrid work flexibility.
- Strong learning environment with cross-functional collaboration.
This position is particularly suitable for experienced TMF professionals aiming to transition into senior oversight roles within the clinical research domain. Senior TMF Specialist Job in Chennai at ICON plc
Important Note
IndiaPharmaJobs.in is an independent pharmaceutical job information platform. We are not affiliated with ICON plc or any other company mentioned above. We only provide job-related information sourced from official announcements for the benefit of job seekers. Candidates are advised to verify all details on the company’s official website before applying. Senior TMF Specialist Job in Chennai at ICON plc
Senior TMF professionals seeking career growth in Chennai should not miss this opportunity. If you meet the eligibility criteria and possess strong expertise in clinical documentation management, submit your application today and take the next step in your pharmaceutical career. Senior TMF Specialist Job in Chennai at ICON plc
