Senior Clinical Systems & eTMF Consultant

Key Responsibilities

• Lead oversight and day-to-day management of the electronic Trial Master File (eTMF), ensuring completeness, quality, and regulatory compliance.
• Perform TMF health assessments, identify gaps, and drive remediation activities.
• Develop and implement TMF quality metrics, governance processes, and ongoing quality review procedures.
• Lead TMF inspection readiness activities, including audit preparation and support for regulatory inspections.
• Partner with Clinical Operations teams to ensure contemporaneous filing and inspection-ready documentation throughout study execution.
• Provide strategic oversight and operational support for the Clinical Trial Management System (CTMS), including process improvements, data quality, reporting, and user support.
• Collaborate with CROs and vendors to ensure appropriate document management and system compliance.
• Develop SOPs, work instructions, and best practices related to clinical systems and TMF management.
• Identify opportunities to improve clinical systems, workflows, and inspection readiness processes.
• Support submission readiness activities as programs advance toward BLA filing.

Qualifications

• Bachelor's degree required; advanced degree preferred.
• 10+ years of experience in Clinical Operations, Clinical Systems, TMF, or Clinical Trial Management.
• Extensive experience managing eTMF systems (Veeva Vault TMF preferred).
• Strong understanding of GCP, ICH guidelines, ALCOA principles, and TMF Reference Model.
• Demonstrated experience leading TMF inspection readiness for FDA and/or EMA inspections.
• Experience supporting BLA, NDA, or MAA submissions preferred.
• Experience overseeing CTMS platforms and associated clinical processes.
• Strong knowledge of CRO oversight and vendor management.
• Proven ability to work independently within a small, fast-paced biotech environment.
• Excellent communication and cross-functional collaboration skills.

Preferred Experience

• Gene therapy, rare disease, or biotechnology experience.
• Experience preparing organizations for regulatory inspections.
• Experience supporting multiple global clinical programs.
• Familiarity with Veeva Vault eTMF, CTMS, and related clinical technologies.