Senior Manager, External Data Management
4 weeks ago
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.
The OpportunityThis 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.
Key Responsibilities- Review clinical trial protocols to determine the external data collection needs within the clinical database.
- Collaborate with cross-functional study team 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.
- Standardize data type specifications and processes to align with clinical trial objectives.
- Oversee external data reconciliation against the clinical database.
- Manage external data cleaning and deliverable timeline expectations.
- 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.
- 3 or more years managerial experience.
- Experience creating record tracking systems.
- Strong collaboration skills, ability to communicate concepts effectively with cross-functional team and vendors.
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.
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