Director, eTMF Management & Inspection Readiness

Director, eTMF Management & Inspection Readiness

Director, eTMF is a strategic leader and TMF Subject Matter Expert responsible for building, owning, and evolving the TMF framework to support clinical studies in a predominantly outsourced operating model. This role drives TMF strategy, governance, and standards, ensuring consistently high-quality, inspection-ready TMF across all programs.

The Director partners closely with Clinical Operations, Quality Assurance, and external partners (CROs/vendors) to ensure robust TMF execution, oversight, and compliance with global regulatory requirements (e.g., ICH-GCP, FDA, EMA). This role also plays a key leadership role in health authority inspections, representing TMF and ensuring organizational readiness.

Key Responsibilities

• Own and lead the TMF framework, including strategy, governance, standards, and operating model to support outsourced clinical trials
• Define and implement TMF processes, standards, and KPIs to ensure consistency, quality, and compliance across studies and vendors
• Provide strategic oversight of TMF across all programs, ensuring alignment with ICH-GCP, TMF Reference Model, and global regulatory expectations
• Lead TMF oversight in an outsourced model, ensuring CRO/vendor accountability for TMF completeness, quality, and timeliness
• Establish and drive TMF health metrics, risk indicators, and escalation pathways across studies
• Serve as the organizational SME for TMF, guiding cross-functional teams and influencing best practices
• Lead and support health authority inspections (FDA, EMA, and other regulatory agencies)
• Ensure continuous inspection readiness
• Act as TMF lead/SME during inspections and audits
• Drive inspection preparation, SME briefing, document retrieval, and response coordination
• Lead inspection findings remediation and CAPA development
• Oversee eTMF system strategy and governance, including system configuration, taxonomy, and metadata standards
• Vendor/system performance and optimization
• Enhancements, releases, and UAT oversight
• Drive TMF quality at scale by establishing QC/QR frameworks and oversight models
• Ensuring effective TMF reconciliation practices across functions and vendors
• Identifying systemic gaps and implementing continuous improvement initiatives
• Provide leadership and oversight to TMF staff and/or vendors, including mentoring and capability building
• Partner cross-functionally with Clinical Operations, Study Teams, QA, Regulatory, and external partners to ensure end-to-end TMF alignment
• Support TMF-related risk management, including proactive identification and mitigation of compliance risks
• Lead or support TMF migrations, system implementations, and vendor transitions

Qualifications

• 8–12+ years of clinical research experience, including significant TMF/eTMF leadership experience
• Proven experience in building and leading TMF frameworks in an outsourced or hybrid operating model
• Deep expertise in TMF strategy, governance, inspection readiness, and health authority inspections (FDA, EMA)
• Strong knowledge of ICH-GCP, TMF Reference Model, and global regulatory requirements
• Extensive experience with eTMF systems (e.g., Veeva Vault TMF or equivalent), including system governance and optimization
• Demonstrated ability to lead cross‑functional initiatives and influence at a senior level
• Experience managing CROs/vendors and holding them accountable for TMF quality and delivery
• Strong leadership, strategic thinking, and decision-making skills
• Excellent communication and ability to represent TMF in regulatory-facing settings

Education

• Bachelor’s degree in Life Sciences, Health Sciences, or related field required
• Advanced degree preferred

Pay range: 90-100/hr *based on expereincce