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 #J-18808-Ljbffr Planet Pharma