Senior Manager, TMF

Role Summary

The role is responsible for supporting the Trial Master File (TMF) in alignment with Genmab’s procedural documents, ICH-GCP guidelines, and regulatory authority expectations. This position is not study-specific but provides overarching support across all Genmab studies, ensuring TMF inspection readiness and assisting with tactical implementation of the electronic TMF (eTMF). The role acts as a TMF Subject Matter Expert (SME) and guides TMF Oversight team members as needed.

Responsibilities

• Act as backup for the TMF Business/Data Owner and TMF Archivist; approve Business/Data Owner tasks as appropriate.
• Drive TMF oversight across all Genmab trials to ensure inspection readiness (quality, completeness, and timeliness of filing); monitor dashboards and reports for trends and outstanding tasks.
• Support eTMF migrations, integrations, archival, and AI initiatives, including chatbot support and data visualization dashboards in collaboration with key stakeholders.
• Respond timely to process-related questions.
• Support functional areas by addressing TMF SME questions, providing updates, and developing workarounds as needed.
• Create content and conduct internal/external TMF trainings.
• Develop TMF processes, plans and templates.
• Support on audit trail reviews, user access reviews, and controlled template management.
• Oversee CRO partners to ensure eTMF tasks are completed per Work Orders/Change Orders, SOPs, and Work Instructions.
• Support the TMF Business Owner with eTMF enhancements and regulatory-aligned change controls.
• Serve as Vice Chairperson on the TMF Health and TMF Indexing Key committee, including select request reviews and major updates.
• Participate and present during inspections/audits as a TMF representative.
• Post-audit support: TMF document collection, post-inspection follow-up, CAPA activities, and action items.
• Represent TMF on governance forums and departmental initiatives (e.g., due diligence, knowledge-sharing sessions, new methodology/procedure development).
• Stay current with ICH-GCP, regulatory standards, and TMF industry updates to ensure ongoing compliance and best practices.
• Support and mentor the TMF Oversight team members.

Qualifications

• Bachelor's Degree required, life sciences preferred.
• Minimum 8 years of experience in clinical research; eTMF experience preferred.
• Expert knowledge of eTMF systems, Veeva Vault preferred.
• Expert knowledge of the eTMF index structure (CDISC TMF Reference Model).
• Extensive experience across drug development phases (discovery to market); Oncology experience preferred.
• Experience with TMF plans, TMF reviews and KQI/KPI assessments.
• Strong knowledge of ICH-GCP, internal SOPs and guidelines; regulatory requirements for clinical trials and regulatory documents.
• Proven ability to drive process improvement and solve complex problems; comfortable with ambiguity and delivering results at senior level.
• Strong stakeholder relationship skills and effective written and oral communication; ability to educate stakeholders and deliver presentations.
• Fluent in English (oral and written); excellent analytical and documentation skills.
• Team player with ability to work independently and demonstrate leadership.

Skills

• TMF management and governance
• eTMF systems and data management
• Regulatory compliance and GCP
• Process improvement and change management
• Stakeholder engagement and vendor oversight
• Documentation, audits, and CAPA management
• Clear and effective communication, presentations, and training

Education

• Bachelor's Degree required; life sciences preferred

Additional Requirements

• Travel expectations not specified; none indicated as essential.
• None beyond standard professional requirements stated above.