Clinical Trials Manager

Revolution Medicines is a global, commercial-state oncology company dedicated to discovering, developing and delivering innovative medicines for patients with RAS-addicted cancers. Leveraging its differentiated RAS(ON) tri-complex inhibitor platform, the company is advancing a broad, integrated portfolio of oral RAS(ON) inhibitors designed to directly target the active, cancer-driving state of RAS. Founded on rigorous scientific inquiry and a willingness to challenge long-held assumptions, Revolution Medicines is committed to changing the trajectory of disease for patients with RAS-addicted cancers worldwide. Our people are united by a shared way of working: follow the science, challenge assumptions, act with urgency and hold ourselves to a high standard of rigor—all in service of patients. The Opportunity: This is a unique opportunity for an experienced Clinical Operations Professional who has technical expertise in managing Phase I-III clinical trials in an industry setting and a strong knowledge of clinical operations, Good Clinical Practice (GCP) and U.S. Food and Drug Administration (FDA) regulatory requirements. Oncology experience is preferred. As the Clinical Trial Manager of Clinical Operations, initially reporting to the Director, Clinical Operations, you will be responsible for Contract Research Organization (CRO) oversight and execution of Revolution Medicines clinical studies. Specifically, you will be responsible for:

• Clinical operations functional activities related to the execution of assigned clinical trials based upon department and corporate goals and objectives.
• Management of clinical studies and vendors to ensure studies are completed on time, within budget and in compliance with Standard Operating Procedures (SOPs), FDA regulations and International Council for Harmonization (ICH)/ GCP guidelines.
• Identify, engage, and manage the activities of clinical CROs and other clinical study providers (e.g., core labs, Electronic Data Capture (EDC) provider, and independent contractors) to execute clinical trials.
• Reviewing and contributing to the development of study-specific documentation including clinical trial protocols, case report forms, study guides/manuals, informed consent forms and clinical database.
• Reviewing monitoring reports and other study documentation as required.
• Oversight of the collection and management of clinical trial documentation to be filed in the Trial Master File (TMF).
• Participation in team meetings and collaboration with other functional groups within the company (e.g., Clinical Development, Pharmacokinetics, Quantitative Sciences, Regulatory, QA, Finance, Legal, etc.) to achieve clinical study goals.
• Following up on assigned team action items and identification, escalation, and resolution of issues as needed.
• Collaboration with contracts specialist to review and negotiate Clinical Trial Agreements and site specific study budgets.
• Assessment of adequacy/feasibility of potential clinical investigators and sites including evaluating facilities, personnel, patient referral base, and adherence to GCP.
• Development of clinical study monitoring priorities and Monitoring Plan in conjunction with CRO.
• Conduct site visits (e.g., training visits, site initiation visits, monitoring visits), as required.
• Managing investigational product accountability and reconciliation process.
• Assistance with the preparation of safety, interim and final clinical study reports, and resolution of data discrepancies.
• Providing clinical trial support, mentoring, leadership, guidance, and direction to Clinical Research Associates (CRAs) assigned to clinical studies.
• Preparation and tracking of study participant enrollment projections vs. actuals and study budgets.
• Serving as primary clinical operations contact for internal and external (clinical sites, vendors, etc.) teams for assigned studies.

Required Skills, Experience and Education:

• BS or MS degree with a minimum of 5 years clinical operations experience in the pharmaceutical or biotech industry, preferably the majority in oncology drug development.
• Direct experience of running early-stage clinical trials within an industry environment.
• Strong working knowledge of FDA Regulations, ICH Guidelines and GCPs governing the conduct of clinical trials.
• Experience in selection of CROs/ vendors and management of external resources.
• A demonstrable record of strong vendor management and teamwork.
• Direct experience of managing clinical CROs.
• Thrives in a collaborative team setting and is driven by a desire to deploy innovative approaches and technologies in a high-energy environment.
• Excellent written and verbal communication skills.
• Demonstrated ability to multi-task, prioritize options, anticipate challenges, and execute on goals as a member of an interdisciplinary team is extremely important.
• Ability to travel (~25%)

Preferred Skills:

• Experience in working with cooperative group studies and investigator sponsored trials, preferred.
• Experience of Global clinical trial operations outside the USA.
• Exceptional knowledge of the APAC region.

#LI-EM1 #LI-HybridThe base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is listed below. The range displayed on each job posting is intended to be the base pay salary range for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our base pay salary ranges are determined by role, level, and location. Individual base pay salary is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training. Please note that base pay salary range is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities. 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. Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact View email address on click.appcast.io. Base Pay Salary Range$106,000-$132,000 USD #J-18808-Ljbffr OpenKrill