Senior Trial Master File (TMF) Specialist Clinical Operations

Why This Role Matters

In 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 Description

The 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 Role

Global clinical trial exposure
Inspection readiness responsibility
Advanced eTMF system involvement (Veeva Vault)
Cross-functional collaboration with study teams
Compliance-driven and quality-focused environment
Opportunity for mentoring and training support
Career progression into TMF Lead or Clinical Operations roles

Responsibilities

• 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 Insights

Compensation 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 options

At ICON plc, total rewards are designed to support professional growth, financial security, and work-life balance.

Company Overview

ICON 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.

FAQs

1. Is Veeva Vault experience mandatory?
   It is highly preferred and considered a strong advantage.

2. Does the role involve regulatory submissions?
   The focus is on TMF oversight rather than direct regulatory submissions.

3. Is inspection readiness a key responsibility?
   Yes, ensuring inspection readiness is a core function of the role.

4. 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.