Senior Manager, External Data Management - Clinical Data Science - REVOLUTION Medicines

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:

This position is responsible for partnering with leaders within Clinical Data Science to define the external data management strategy and leading its execution in partnership with cross-functional teams. Identifies requirements for capturing and processing of clinical data ensuring accuracy, consistency, and completeness for analysis. Manages external vendors reviewing and providing clinical data. Oversees and/or performs data management tasks ensuring alignment with clinical trials' objectives and regulatory standards. This position will report to the Senior Director, Head of Clinical Data Science.

Specific Responsibilities

• Review clinical trial protocols to determine the external data (biosamples, ECGs, etc.) collection needs within the clinical database (Case Report Forms).

• Collaborate with cross-functional study team especially Clinical Operations and the Lead Data Manager, as well as Biomarker Operations, Data Analytics, Medical, Statistics, etc. and external partners to ensure adherence to RevMed’s requirements and timelines.

• Assess vendor contracts including central laboratories, setup specifications, and test data transfers.

• Review external data vendor lab systems specifications and manuals.

• Develop detailed data transfer specifications for acquiring external data from third-party vendors to be maintained outside of the clinical database.

• Standardize data type specifications and processes to align with clinical trial objectives.

• Oversee (Data Management CRO or internal resources) and/or perform external data reconciliation against the clinical database.

• Manage external data cleaning and deliverable timeline expectations.

• Oversee direct reports as applicable.

• Provide training of direct reports, department colleagues, and cross-functional team as applicable.

Required Skills

• Bachelor’s degree in science or related field

• 10 years biotech/pharma industry experience with at least 5 years focus on external data experience and experience managing a team

• A proven track record in effectively managing CRO/service providers

• Working knowledge and understanding of FDA and ICH regulations and industry standards and quality control principles.

• Experience applying Good Documentation Principles

• Proven project and time management skills

• Early Development experience focusing on e.g., dose finding, healthy volunteer

Preferred Skills

• 3 or more years managerial experience

• Experience creating record tracking systems preferred

• Strong collaboration skills, ability to communicate concepts effectively with cross-functional team and vendors

The expected salary range for this role is $150,000 to $190,000. An individual’s position within the range may be influenced by multiple factors, including skills and experience in role, overall performance, individual impact and contributions, tenure, location, and market dynamics. 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.

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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