TMF Operations Specialist

Job Purpose

We’re looking for a highly organized and detail‑oriented TMF Specialist to join our Clinical Operations team and play a key role in ensuring excellence across our clinical documentation processes.
In this role, you will be responsible for the end‑to‑end management, oversight, and quality of the Trial Master File (TMF), ensuring compliance with regulatory requirements and internal standards. You will lead the development and maintenance of the TMF Plan and Index, drive inspection readiness, and ensure seamless alignment with other clinical systems.
A major part of the role includes oversight of CRO TMF activities—monitoring performance, tracking KPIs, and ensuring documentation is complete, accurate, and timely. You will oversee both electronic and paper TMFs (where relevant), apply a risk‑based approach to document management, and provide guidance on documentation maintained within the Investigator Site File (ISF).
Beyond TMF responsibilities, this role supports broader R&D Operations, including coordinating study‑related contracts with vendors and service providers.
You will also contribute to continuous improvement and innovation, including exploring and implementing enhanced approaches to TMF and operational management—leveraging AI‑enabled tools to increase efficiency, quality, and inspection readiness.
If you’re passionate about quality, operational excellence, and shaping how clinical documentation is managed in a growing R&D organization, we’d love to hear from you.

Key Responsibilities

TMF Oversight & Compliance
• Oversee the setup, maintenance, and archiving of the TMF for clinical trials.
• Ensure the TMF is inspection ready and compliant with ICH GCP, regulatory requirements, and company SOPs.
• Apply a risk based approach to TMF management, prioritizing critical documents and processes.
• Manage both electronic and paper TMFs when applicable.
• Ensure essential records are collected and archived according to the TMF Index.
• Provide guidance and support for documents maintained within the Investigator Site File (ISF).
• Ensure documentation from external providers is captured in the TMF Index and archived appropriately.
Quality, KPIs & Audit Readiness
• Conduct regular TMF quality checks and internal audits to ensure completeness and accuracy.
• Monitor CRO KPIs with a focus on TMF quality, completeness, and timeliness.
• Support internal and external inspections by ensuring all documentation is complete and accurate.
• Support new acquisitions through TMF and study documentation/data quality checks and gap remediation.
CRO & Vendor Oversight
• Oversee CRO performance related to TMF activities and adherence to timelines and quality standards.
• Support TMF migrations from external partners, including CROs and acquired companies/products, ensuring accurate mapping, completeness checks, and compliance during transfer
• Ensure integration of the TMF with other study systems and tools.
Documentation Strategy & System Leadership
• Create and maintain the TMF Plan and TMF Index.
• Monitor active users in the TMF system, ensuring appropriate access and security.
• Ensure tracking of all Recordati sponsor studies within internal systems.
• Generate and present TMF status reports to senior management and project teams.
Training, Collaboration & Cross Functional Support
• Provide training and support to clinical team members on TMF processes and best practices.
• Collaborate with study start up functions, Clinical Study Managers, CRAs, and cross functional teams to ensure timely documentation.
• Support broader R&D Operations through coordination of study related contracts and vendor invoicing against milestones.

Required Education

Bachelor’s degree in Life Sciences, Clinical Research, or a related field.

Required Skills and Experience

• Experience: Minimum of 3-5 years of experience in TMF management within the pharmaceutical or CRO industry.
• Knowledge: Strong understanding of ICH-GCP guidelines and regulatory requirements for clinical trials.
• Skills: Excellent organizational, communication, and interpersonal skills. Proficiency in TMF management systems, specifically Veeva, and Microsoft Office Suite.
• Attention to Detail: High level of accuracy and attention to detail in managing documentation.
• Problem-Solving: Ability to identify and resolve issues related to TMF management.

Technical Competencies

Proficiency in TMF management systems, specifically Veeva, and Microsoft Office Suite.

Required Behaviours and Competencies

• Teamwork: Strong ability to work collaboratively within a team environment.
• Problem-Solving: Excellent problem-solving skills with a proactive approach to identifying and addressing issues
• Role works in close collaboration with Clinical Operations Teams, Medical Monitoring, Study Start up, Regulatory Affairs, Quality Assurance, and other functions, as appropriate.

Required Languages

English: full professional proficiency (written and spoken) is required.