Clinical TMF Manager, Clinical Operations

Revolution Medicines is a late‑stage clinical oncology company developing novel targeted therapies for patients with RAS‑added cancers. The company’s R&D pipeline includes RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins: 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, all currently in clinical development. As a new member of the Revolution Medicines team, you will join outstanding professionals in a tireless commitment to patients with cancers bearing RAS signaling pathway mutations. The Opportunity This is a unique opportunity for a Clinical Operations Professional. As a Clinical TMF and Systems Manager, you will be the central contact for Clinical Study Execution Teams (CSETs) for Trial Master File (TMF) management and will help develop quality oversight processes for TMF management of Revolution Medicines’ clinical trials. Your additional responsibilities include uploading, reviewing, and approving TMF documents; co‑authoring and managing TMF documents such as the TMF Plan, Index, SOPs, and other guidance documents; and ensuring quality management by reporting TMF metrics, conducting periodic checks of adherence to SOPs, and reconciling all outstanding queries and issues (e.g., CAPAs). You will support Clinical Operations Management in high‑level projects, develop processes and strategies, and conduct training for TMF stakeholders. You will oversee the activities of the TMF Specialist(s) and external vendors, ensuring that study documents adhere to ICH‑GCP guidelines, other regulatory requirements, and internal and external SOPs, making their assigned studies inspection‑ready. Responsibilities Adhere to Clinical Standard Operating Procedures (SOPs) and Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) Guidelines. Be the primary lead with eTMF and CTMS integration/implementation/maintenance, user training, team advisor, and assist in managing oversight for the company’s TMFs and CTMS within timelines and program budgets. Provide strong support to establish and manage quality oversight of TMF and CTMS, including TMF metrics and KPIs. Partner with CSETs, CROs/vendors and cross‑functional team members to align TMF activities, as needed. Manage the vendor and internal implementation and maintenance process for cataloguing, 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 the review process, ensuring TMF completeness, and managing the transfer of TMF records, as needed. Provide TMF SME audits and inspections support. Contribute to and implement TMF planning and strategy development, which may include evaluation of possible on‑site and off‑site locations. Use all available tools to track, analyse, oversee, and report CTMS and TMF health metrics and status to all key stakeholders. May be responsible for direct TMF management activities for assigned study TMFs. Contribute to risk, contingency, and scenario planning. Analyse and report TMF health metrics by study to stakeholders. Supervise, communicate system status, issues and problem‑solve 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/or co‑lead departmental or inter‑departmental strategic business initiatives, as well as contribute to SOP development, implementation, and training. Manage staff through mentorship and may supervise TMF specialists or similar as direct reports. Assist in the hiring, development, and retention of top talent within the team. Coach direct reports on performance, development, and career interests. Participate in other Clinical Operations activities as appropriate. Required Skills, Experience and Education RN or bachelor’s or master’s degree desired. Minimum of 8+ years working in a pharmaceutical or other highly regulated corporate environment. Minimum of 6 years’ experience working in the Records Management field, including 4+ years of experience using electronic records management systems. Relevant indirect experience may also meet this requirement. Strong experience collaborating with the DIA (CDISC) TMF Reference Model. Strong working knowledge of FDA regulations, ICH guidelines, and GCP. Strong experience in Trial Master File requirements and set‑up. Strong knowledge of electronic document management systems, document archival systems (eTMF) and CTMS systems. A clear understanding of the clinical development lifecycle and the technologies associated with activation and management of clinical trials and study sites. Ability to successfully oversee study TMFs, including development of relevant processes and policies. Experience in selection of CROs/vendors and management of external resources. Thrives in a collaborative team setting that demonstrates flexibility required to maintain a fast pace and is driven by a desire to deploy innovative approaches and technologies in a high‑energy environment. Excellent written/verbal communication and people skills. Strong decision‑making skills. High sense of priority and commitment to excellence in delivering deliverables. Ability to analyse operational data, contribute with a mindset focused on quality, timeliness and fiscal responsibility, drive decisions, multi‑task, prioritise tasks, anticipate challenges, and execute on goals as a member of the Clinical Operations Process and Systems team. Demonstrate proficiency in Microsoft Office Suite (Outlook, MS Word, Excel, PowerPoint); MS Project and/or Smartsheet a plus. Travel may be required (~25%). Preferred Skills Direct experience working with eTMF systems. Familiarity collaborating with vendor systems/portals (e.g., CTMS). Oncology experience, early and/or late stage, preferred. Knowledge and/or familiarity with Ex‑US regions clinical trial operations. Experience managing direct reports(s). Base Pay Salary Range

$143,000 - $178,000 USD

Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status. #J-18808-Ljbffr Revolution Medicines