Clinical TMF Manager, Clinical Operations

Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. As a new member of the Revolution Medicines team, you will join other outstanding professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway. The Opportunity: This is a unique opportunity for a Clinical Operations Professional. As a Clinical TMF and Systems Manager you will be responsible for acting as a central contact for the Clinical Study Execution Teams (CSETs) for Trial Master File (TMF) management and participating in the development of quality oversight processes for TMF management of RevMed’s clinical trials. Additional responsibilities include the upload, review, and approval of TMF documents, co-authoring and managing TMF documents such as TMF Plan, Index, SOPs, and other guidance documents and ensuring quality management by reporting TMF metrics, periodic checks of adherence to SOPs, and reconciling all outstanding queries and issues (e.g., CAPAs). Support Clinical Operations Management in high-level projects, developing processes, strategies and conducting training for TMF stakeholders. Responsible for overseeing the activities of the TMF Specialist(s) and external vendors, ensuring that study documents are adherent with ICH-GCP guidelines, other regulatory requirements, and internal and external standard operating procedures (SOPs) and that their assigned studies are inspection-ready. Responsibilities: Adhere to Clinical Standard Operating Procedures (SOPs) and Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) Guidelines Be a primary lead with eTMF and CTMS integration/implementation/maintenance, user training, team advisor and assist in managing oversight for the RevMed clinical trial TMFs and CTMS within timelines and designated program budgets. Provide strong support to establish and manage quality oversight of TMF and CTMS, including TMF metrics and KPIs. Partner with Clinical Study Execution Teams (CSETs), CROs/vendors and cross-functional team members to align TMF activities, as needed. Responsible for vendor and internal implementation and maintenance process for cataloging, filing, retrieving, storing, preserving, and protecting CTMS outputs and TMF records (paper and electronic). Develop successful working relationships with service providers (vendors) and CROs on TMF management including review process, ensuring TMF completeness and managing the transfer for TMF records as needed. Provides TMF SME audits and inspections support. Contributes to and implements TMF planning and strategy development, which may include evaluation of possible options for on and off-site locations. Use all available tools to track, analyze, oversee, and report CTMS and TMF health metrics and status to all key stakeholders. May be responsible for direct TMF management activities, e.g., for assigned study TMF(s) Responsible for contributing to risk management, contingency and scenario planning. Analyze and report TMF health metrics by study to be shared with stakeholders. Supervise, communicate system status, issues and problem solves to ensure project team goals are met. Actively contribute to the selection and management of eTMF, CTMS and other Clinical System solutions / vendors, including development of Requests for Proposals (RFPs) Anticipate obstacles, difficulties, be solution-oriented, proactively provide risk assessment and mitigation strategies to achieve goals. Participate in and/o