Director, TMF Operations

📋 Description

• Lead the TMF operating model, which encompasses strategy, governance, standards, and operational frameworks to support the portfolio.

• Define and execute TMF processes, standards, and key performance indicators (KPIs) to foster consistency, quality, and compliance across studies and vendors, applying a risk-based approach to ensure sponsor oversight.

• Supervise TMF across all programs, guaranteeing alignment with ICH-GCP, the TMF Reference Model, and global regulatory expectations.

• Direct TMF oversight within an outsourced model, ensuring CRO/vendor accountability for TMF completeness, quality, and timeliness, along with dashboards and governance reporting to senior leadership.

• Establish and promote TMF health metrics, risk indicators, and escalation pathways throughout studies.

• Act as the TMF subject matter expert, advising cross-functional teams, promoting best practices, supporting role-based training for sponsor and CRO teams, and tracking adoption and uptake through metrics and governance.

• Lead and facilitate TMF-related activities for health authority inspections (FDA, EMA, and other regulatory agencies).

• Ensure continuous inspection readiness by defining, implementing, and enhancing the TMF/eTMF operating model and performance program.

• Serve as the TMF lead/SME for TMF-related inspections and quality assurance audit activities.

• Manage TMF inspection preparation, subject matter expert briefing, document retrieval, and response coordination, including TMF demonstrations, evidence packages, and remediation planning.

• Lead or assist with remediation and CAPA development for TMF-related inspection findings.

• Drive the eTMF system strategy and governance, which includes:

• System configuration, taxonomy, and metadata standards.

• Oversee cross-system TMF artifact mapping and reconciliation across eTMF, CTMS, eDC, safety, regulatory, and QMS to facilitate trial reconstruction.

• Optimize vendor/system performance.

• Collaborate with CBO Ops, IT, and quality systems on validation and change control for eTMF and related systems, as applicable.

• Oversee enhancements, releases, and user acceptance testing (UAT).

• Promote TMF quality at scale by:

• Establishing quality control/quality review frameworks and oversight models.

• Implementing effective TMF reconciliation practices across functions and vendors.

• Identifying systemic gaps and executing continuous improvement initiatives.

• Provide leadership and oversight to TMF staff and/or vendors, including mentoring and capability development.

• Work collaboratively with Clinical Operations, Study Teams, QA, Regulatory, and external partners to ensure end-to-end TMF alignment.

• Lead and support TMF-related risk management, including the proactive identification and mitigation of compliance risks.

• Lead or assist with TMF migrations, system implementations, and vendor transitions.

• Collaborate with Procurement/Legal and Alliance Management to incorporate TMF expectations in contracts and statements of work (SOWs) (access, reporting, audit rights, inspection support).

⛳️ Requirements

• BS/BA degree required; an advanced degree is highly preferred.

• 8–12+ years of clinical research experience, including substantial TMF/eTMF leadership experience.

• Proven track record in developing and leading TMF frameworks in an outsourced or hybrid operating model.

• Extensive expertise in TMF strategy, governance, inspection readiness, and health authority inspections (FDA, EMA).

• Strong understanding of ICH-GCP, the TMF Reference Model, and global regulatory requirements.

• Significant experience with eTMF systems (e.g., Veeva Vault TMF or equivalent).

• Experience managing CROs/vendors and holding them accountable for TMF quality and delivery.

• Excellent communication skills and ability to represent TMF in regulatory-facing environments.

• Demonstrated proficiency in managing complex projects and effectively handling multiple projects/priorities.

• Proven ability to solve problems with innovative solutions, complemented by strong organizational skills.

• Demonstrated capability to lead cross-functional initiatives and influence at senior levels.

• Strong leadership, strategic thinking, and decision-making abilities.

🏝️ Benefits

• Medical, dental, and vision insurance.

• 401(k) plan.

• Unlimited paid time off.

• Parental leave.