Clinical Operations and TMF Specialist

Keeping clinical trials audit-ready through expert TMF oversight and operational excellence.

R&D Partners is seeking a Clinical Operations and TMF Specialist to support Trial Master File (TMF) operations for clinical trials. This role ensures compliance with ICH-GCP guidelines, regulatory requirements, and company SOPs, maintaining inspection readiness and alignment with trial management strategies.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities:

• Initiate study setup in the Clinical Operations system during the start-up phase.
• Onboard internal and external study team members, ensuring role-based training and system access.
• Customize study-specific TMF Plans and TMF Indexes with input from relevant team members.
• Act as the primary contact for training, user support, and adherence to good documentation practices.
• Fulfill the Clinical Business Admin role and provide operational support to study teams.
• Review and approve clinical study documents in the eTMF based on ALCOA data integrity principles.
• Monitor eTMF health metrics, report risks, and follow up on mitigation strategies.
• Conduct periodic risk-based TMF reviews to ensure inspection readiness and document quality.
• Oversee Sponsor oversight of clinical study documentation in ESP eTMF systems.
• Ensure proper archiving or disposal of hardcopy clinical study documents upon study completion.
• Drive preparation activities for inspections and audits, participating in meetings and interviews as required.
• Contribute to the development of TMF processes and best practices.
• Oversee FSP team activities and evaluate performance against agreed KPIs.

Key Skills and Requirements:

Required:

• University degree in Life Sciences (preferred but not mandatory).
• 2-3 years of experience in clinical drug development, pharmaceutical companies, or CROs.
• Strong understanding of clinical trial processes and medical-clinical study documentation.
• Knowledge of ICH-GCP and regulatory requirements for clinical study documentation.
• 2-3 years of experience working with TMF systems and processes.
• Proficiency in MS Office and electronic document management systems.
• Excellent written and verbal communication skills in English.

Desired:

• Working knowledge of TMF management strategies and best practices.
• Familiarity with Veeva Clinical Vault.

Personal Attributes:

• Team-oriented with a willingness to share ideas and knowledge.
• Flexible and communicative, able to adapt to shifting priorities.
• Strong analytical and problem-solving skills.
• Proactive and independent approach to project work.

For more information, please contact Elliott Croft.

If you are interested in applying to this exciting opportunity, then please click ‘Apply’ or to speak to one of our specialists visit the ‘Contact Us’ page.

R&D Partners is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. R&D Partners is acting as an Employment Agency in relation to this vacancy.

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