Associate Director, Clinical TMF Management (Clinical Operations)

The Opportunity:

This is a unique opportunity for a Trial Master File (TMF) Management Professional who has innate leadership and organizational skills, technical expertise in clinical Trial Master File management in an industry setting, and experience in the development and implementation of clinical systems strategy. As Associate Director Clinical TMF Management, you will be a key member of the Clinical Operations Excellence (CORE) team, responsible for the development and oversight of the Trial Master File strategy and standards, in support of Revolution Medicines (RevMed) clinical trials.

Responsibilities:

• Adhere to Clinical Standard Operating Procedures (SOPs) and Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) Guidelines.

• Serve as a key leader within Clinical Operations Excellence (CORE), a subfunction of Clinical Operations., providing strategic leadership and oversight of TMF activities across the RevMed portfolio.

• Accountable for strategic leadership and continuous improvement of Trial Master File (TMF) activities, ensuring scalable infrastructure and sustained inspection readiness across clinical programs.

• Lead and develop a team of CORE TMF Managers responsible for:

• Administration and operational oversight of the internal RevMed TMF, including management of the eTMF system vendor.

• Partnering with Clinical Study Teams to provide expert guidance and risk-based oversight to support high-quality TMF management.

• Supporting internal and CRO-managed study TMF start-up, ongoing quality oversight, close-out, and migration activities.

• Contributing to inspection readiness strategy and execution.

• Establish and maintain clear TMF governance and role delineation. Clinical study teams retain accountability for their study-specific TMFs; the AD, TMF Management ensures standards, oversight frameworks, tools, and support mechanisms enable consistent quality and compliance.

• Oversee internal and CRO-maintained TMFs to ensure alignment with RevMed standards, the CDISC TMF Reference Model, and global regulatory requirements.

• Develop and advance TMF strategy, processes, standards, SOP development, and quality frameworks to ensure completeness, timeliness, and audit readiness throughout the clinical trial lifecycle.

• Champion innovation in TMF management through implementation of technology-enabled and AI-supported solutions to enhance document quality, reconciliation, reporting, and inspection preparedness.

• Lead TMF-related vendor and CRO oversight, including expectation setting at study start-up, monitoring TMF health metrics and KPIs, proactive risk identification, and timely issue escalation and resolution, budget and resource strategy.

• Establish and monitor TMF performance dashboards and key risk indicators; conduct trend analysis and implement sustainable mitigation strategies to drive operational excellence.

• Identify critical path TMF risks and implement proactive mitigation strategies to protect study timelines, regulatory submissions, and inspection readiness.

• Provides strategic oversight, document strategy support, and remediation leadership as required during audits and regulatory inspections.

• Oversee TMF system strategy and optimization, including vendor management, system enhancements, integrations, and continuous improvement aligned with broader clinical systems strategy.

• Supervise, communicate system status, issues and problem solve to ensure TMF project goals are met.

• May manage or participate in implementation, development or management of other clinical systems and system integrations.

• Participate in and/or co-lead departmental or interdepartmental strategic business initiatives.

• Lead TMF training, cross-functional collaboration, and continuous improvement initiatives to strengthen quality, efficiency, scalability, and long-term sustainability.

• Drive line management responsibilities including hiring, performance management, mentorship, succession planning, and development of a high-performing CORE TMF team.

• Contribute TMF expertise to broader Clinical Operations and CORE strategic priorities.

• Participate in other Clinical Operations activities as appropriate.

Required Skills, Experience and Education:

• RN or Bachelor’s or Master’s degree in a science, health-related, or industry-related discipline required. Relevant equivalent experience may be considered.

• 11+ years of progressive experience in pharmaceutical, biotech, or other highly regulated environments.

• Minimum 7–10 years of direct industry experience in TMF/eTMF management, including leadership of TMF strategy, governance, implementation, and oversight within global clinical development programs.

• Minimum 5 years of people management experience, with demonstrated ability to build, lead, and develop high-performing teams.

• Proven experience establishing and advancing TMF strategy, standards, governance models, and inspection readiness frameworks across multiple studies or programs.

• Strong experience overseeing internal and CRO-managed TMFs, including vendor oversight, performance management, risk identification, and issue resolution.

• Demonstrated expertise with the CDISC TMF Reference Model and deep working knowledge of FDA regulations, ICH Guidelines, and GCP.

• Experience supporting regulatory inspections and audits, including preparation strategy, document readiness, and remediation leadership.

• Strong technical expertise in eTMF platforms and clinical systems, including vendor oversight, system optimization, and cross-system integration considerations.

• Experience driving technology-enabled process improvements, including familiarity with or application of AI-enabled tools to enhance TMF quality control, reconciliation, reporting, or inspection preparedness.

• Clear understanding of the clinical development lifecycle and the operational and regulatory interdependencies that impact TMF completeness and compliance.

• Proven ability to develop and implement SOPs, policies, metrics, dashboards, and quality frameworks supporting sustainable TMF oversight.

• Strong analytical and strategic thinking skills, with demonstrated ability to interpret operational data, identify trends, mitigate risk, and implement scalable solutions.

• Demonstrated ability to perform complex analysis, draw sound conclusions, and implement appropriate corrective and preventive actions.

• Experience managing vendor relationships, budgets, timelines, and resource planning within a clinical operations framework.

• Ability to operate effectively in a fast-paced, evolving environment; prioritize competing demands; and maintain focus on long-term inspection readiness and organizational scalability.

• Strong leadership presence with excellent interpersonal, negotiation, and written and verbal communication skills.

• Demonstrated proficiency in Microsoft Office Suite (Outlook, Word, Excel, PowerPoint); MS Project and/or Smartsheet a plus.

• Travel may be required (~25%).

Preferred Skills:

• Demonstrated experience leveraging AI-enabled or advanced technology solutions to enhance TMF quality control, document completeness review, reconciliation, reporting, analytics, and inspection readiness.

• Experience contributing to or leading clinical systems strategy initiatives, including eTMF system selection, implementation, optimization, validation support, and cross-functional integration.

• Experience overseeing or supporting record management strategies for Externally Sponsored Research, Expanded Access programs, or other non-traditional study models.

• Familiarity working with other systems/portals (e.g., CTMS, EDC),

• Experience working within or oversight of a Learning Management System (LMS).

• Oncology experience, early and/or late stage, strongly preferred.

• Knowledge of global clinical trial operations, including Ex-US regulatory and operational considerations.

• Experience working with Trial Interactive and Veeva systems. 

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