Director, eTMF Management & Inspection Readiness

Director, eTMF Management & Inspection ReadinessDirector, 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 ResponsibilitiesOwn and lead the TMF framework, including strategy, governance, standards, and operating model to support outsourced clinical trialsDefine and implement TMF processes, standards, and KPIs to ensure consistency, quality, and compliance across studies and vendorsProvide strategic oversight of TMF across all programs, ensuring alignment with ICH-GCP, TMF Reference Model, and global regulatory expectationsLead TMF oversight in an outsourced model, ensuring CRO/vendor accountability for TMF completeness, quality, and timelinessEstablish and drive TMF health metrics, risk indicators, and escalation pathways across studiesServe as the organizational SME for TMF, guiding cross-functional teams and influencing best practicesLead and support health authority inspections (FDA, EMA, and other regulatory agencies)Ensure continuous inspection readinessAct as TMF lead/SME during inspections and auditsDrive inspection preparation, SME briefing, document retrieval, and response coordinationLead inspection findings remediation and CAPA developmentOversee eTMF system strategy and governance, including system configuration, taxonomy, and metadata standardsVendor/system performance and optimizationEnhancements, releases, and UAT oversightDrive TMF quality at scale by establishing QC/QR frameworks and oversight modelsEnsuring effective TMF reconciliation practices across functions and vendorsIdentifying systemic gaps and implementing continuous improvement initiativesProvide leadership and oversight to TMF staff and/or vendors, including mentoring and capability buildingPartner cross-functionally with Clinical Operations, Study Teams, QA, Regulatory, and external partners to ensure end-to-end TMF alignmentSupport TMF-related risk management, including proactive identification and mitigation of compliance risksLead or support TMF migrations, system implementations, and vendor transitionsQualifications8–12+ years of clinical research experience, including significant TMF/eTMF leadership experienceProven experience in building and leading TMF frameworks in an outsourced or hybrid operating modelDeep expertise in TMF strategy, governance, inspection readiness, and health authority inspections (FDA, EMA)Strong knowledge of ICH-GCP, TMF Reference Model, and global regulatory requirementsExtensive experience with eTMF systems (e.g., Veeva Vault TMF or equivalent), including system governance and optimizationDemonstrated ability to lead cross‐functional initiatives and influence at a senior levelExperience managing CROs/vendors and holding them accountable for TMF quality and deliveryStrong leadership, strategic thinking, and decision-making skillsExcellent communication and ability to represent TMF in regulatory-facing settingsEducationBachelor's degree in Life Sciences, Health Sciences, or related field requiredAdvanced degree preferredPay range: 90-100/hr *based on expereincce#J-18808-Ljbffr