Associate Director – Director, eTMF

Your role:

• As Director eTMF, you will act as the TMF Subject Matter Expert for the clinical study team and support cross-functional departments to ensure high-quality documentation. 
• Lead and manage the setup and ongoing review of studies within the Veeva system, acting as a Veeva Vault Expert. 
• Be responsible for the setup, management, archiving processes, and execution of Vault, including naming conventions, processes, migrations, etc.
• Ensure the TMF(s) for each program are compliant and ready for inspections by auditors and regulatory authorities (TMFs with CRO partners and the internal Veeva Vault system).
• Drive and enforce timelines with a sense of urgency to meet clinical trial deadlines, as well as corporate/department goals and objectives.
• Lead the development of procedural documents, SOPs, etc., and oversee the creation of individual project TMF management plans and related materials.
• Act as a primary point of contact for project teams for guidance, oversight, metric creation, and review, as well as a key liaison for CROs, auditors, IT, and external parties.
• Review and resolve discrepancies within eTMFs, ensuring timely reporting and internal reviews.
• Participate in clinical operations meetings, audits, and inspection readiness activities, ensuring smooth preparation.
• Identify and implement continuous process improvements in collaboration with stakeholders.
• Manage budget proposals from third parties related to eTMF activities or systems, ensuring alignment with business needs.
• Lead and direct staff to ensure documentation activities comply with GCP, SOPs, and regulatory requirements.
• Guide and provide metrics for CRO and internal TMF systems to reflect TMF status and health accurately.
• Oversee access management and ensure appropriate internal and external access to the eTMF system. Be the system owner and expert for Veeva Vault at Merus.
• Ensure compliance with global regulations and guidelines for TMF management, staying current with changes in industry standards.

Your Profile:

• Bachelor’s degree or international equivalent in information management, library science, clinical science, or a related field.
• 8-10 years of TMF management experience in global clinical trials.
• Experience with computerized clinical trial records management technologies, particularly Veeva systems.
• 4-5 years of personnel management experience, with a proven track record of mentoring and developing teams.
• Strong organizational, writing, and communication skills.
• Advanced knowledge of ICH/GCP guidelines, FDA regulations, and international TMF regulatory requirements.

Our offer