Senior Clinical Data Manager

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers.  The company’s R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. 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: 

• Responsible for all aspects of the data management process, from developing project documentation, system set-up, User Acceptance Testing (UAT), and routine data review through database lock of clinical trials.  

• Represent data management in study team meetings, facilitate and provide data management updates and input when appropriate. 

• Manage data management timelines to coordinate and synchronize deliverables with the study timelines. Generate, review, and approve study documents (e.g., Data Management Plans, Case Report Forms, DB build specifications, data transfer specifications, SAE (Serious Adverse Events) and external data reconciliation plans, coding conventions, laboratory data handling plans, and study protocols). 

• Review protocols for appropriate data capture, including electronic Case Report Form (eCRF) design and external data vendors’ systems. 

• Provide oversight of database set-up/migrations/updates, including coordinating and performing UAT. 

• Lead the development of the internal Data Review Plan and coordinate cross-functional team data listing review. 

• Coordinate the internal medical coding review. 

• Perform ad hoc and scheduled data listing reviews and generate and resolve queries in EDC (Electronic Data Capture). 

• Perform external data reconciliation against EDC. 

• Perform SAE reconciliation according to SOPs (Standard Operating Procedures) and guidelines. 

• Execute and distribute data management metrics, listings, and reports. 

• Provide oversight of data management CRO (Contract Research Organization) and service providers, including managing and monitoring the progress of data management activities with CROs and other service providers on assigned studies. 

• Build effective relationships with CRO and service provider counterparts. 

• Review and provide feedback to the clinical team on other study documents (e.g., Clinical Monitoring plans and vendor specifications). 

• Provide training on the EDC system and CRF (Case Report Form) completion guidelines and EDC system to internal or external study team members, as needed. 

• Proactively identify potential study issues and risks and recommend and implement solutions. 

• Maintain study DM-related documents and files for inspection readiness. 

• Provide DM support to Statisticians and Statistical Programmers in producing clinical trial reports and other deliverables. 

• Assist with the training of new employees and contractors (e.g., clinical data associates and junior clinical data managers working on the studies). 

• Participate in the CRO and vendor selection process for outsourced activities. 

• Support budget and resource planning across assigned projects. 

• Participate in the development, review, and implementation of departmental SOPs, templates, and processes.

Required Experience, Skills, and Education: 

• Bachelor’s degree or equivalent in Health Sciences, Life Sciences, Mathematics, Computer Science or Health related field. 

• Five (5) years of progressive experience in Clinical Data Management.

• Academic background, Internship, or work experience to include:

• Electronic Data Capture (EDC) Systems including: Medidata RAVE, Medrio, or OpenClinica

• Clinical Data Interchange Standards (CDISC)

• International Council for Harmonisation Good Clinical Practices (ICH GCP) Guidelines

• Electronic Data Capture (EDC) Design, data collection, review and discrepancy management

• External Data Reconciliation

• Vendor Management

• Medical coding

• Database Lock

• This position allows for a hybrid work arrangement. The employee must reside in the SF Bay Area and may work remotely two (2) days per week.

• Successful completion of background and employment history verification required.

The base salary range for this full-time position is $188,885 to $188,885 for candidates working onsite at our headquarters in Redwood City, CA. The range displayed on each job posting is intended to be the salary for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our salary ranges are determined by role, level, and location. Individual pay is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.

Please note that base salary 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 privacy@revmed.com.

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