Director, eTMF Management & Inspection Readiness
Planet Pharma, New Haven, CT, United States
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
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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
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