Director, eTMF Management & Inspection Readiness

Job description

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

Worksite address

new haven, CT, 06540, US

Who can apply

Review the original listing for work authorization, qualifications and employer requirements.