Director eTMF

Director eTMF - Permanent - Cambridge, MA

Proclinical is seeking a Director for the electronic Trial Master File (eTMF) team.

Primary Responsibilities:

The successful candidate will lead the eTMF team, ensuring that all activities are managed effectively and that the Trial Master File is always ready for inspection. This position focuses on maintaining high-quality documentation and compliance with regulatory standards.

Skills & Requirements:

• Bachelor's degree or equivalent in information management, library science, clinical science, or related field.
• Extensive experience with Veeva Quality systems and training eTMF staff.
• Experience in TMF management for global clinical trials.
• Familiarity with computerized clinical trial records management technologies, especially Veeva systems.
• Proven personnel management experience with team development skills.
• Strong organizational, writing, and communication abilities.
• Advanced knowledge of ICH/GCP guidelines, FDA regulations, and international TMF requirements.

The Director eTMF's responsibilities will be:

• Serve as the TMF Subject Matter Expert for clinical study teams, supporting cross-functional departments.
• Lead the setup and ongoing review of studies within the Veeva system, acting as a Veeva Vault Expert.
• Manage the setup, archiving processes, and execution of Vault, including naming conventions and migrations.
• Ensure TMFs are compliant and inspection-ready for auditors and regulatory authorities.
• Drive timelines to meet clinical trial deadlines and corporate goals.
• Develop procedural documents and oversee the creation of project TMF management plans.
• Act as a primary contact for project teams, providing guidance and oversight.
• Review and resolve discrepancies within eTMFs, ensuring timely reporting.
• Participate in clinical operations meetings and inspection readiness activities.
• Identify and implement process improvements with stakeholders.
• Manage budget proposals related to eTMF activities, aligning with business needs.
• Lead staff to ensure compliance with GCP, SOPs, and regulatory requirements.
• Provide metrics for CRO and internal TMF systems to reflect TMF status accurately.
• Oversee access management for the eTMF system, being the system owner and expert.
• Ensure compliance with global regulations and stay current with industry standards.

If you are having difficulty in applying or if you have any questions, please contact Ciara Noble at c.noble@proclinical.com

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.