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 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 rigorall 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 andsite 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.

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