Senior Manager, External Data Management - Clinical Data Science at Revolution Medicines
Redwood City, CA 94061
About the Job
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 ResponsibilitiesReview 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 SkillsBachelor’s degree in science or related field10 years biotech/pharma industry experience with at least 5 years focus on external data experience and experience managing a teamA proven track record in effectively managing CRO/service providersWorking knowledge and understanding of FDA and ICH regulations and industry standards and quality control principles.Experience applying Good Documentation PrinciplesProven project and time management skillsEarly Development experience focusing on e.g., dose finding, healthy volunteerPreferred Skills3 or more years managerial experienceExperience creating record tracking systems preferredStrong collaboration skills, ability to communicate concepts effectively with cross-functional team and vendorsThe 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
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 ResponsibilitiesReview 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 SkillsBachelor’s degree in science or related field10 years biotech/pharma industry experience with at least 5 years focus on external data experience and experience managing a teamA proven track record in effectively managing CRO/service providersWorking knowledge and understanding of FDA and ICH regulations and industry standards and quality control principles.Experience applying Good Documentation PrinciplesProven project and time management skillsEarly Development experience focusing on e.g., dose finding, healthy volunteerPreferred Skills3 or more years managerial experienceExperience creating record tracking systems preferredStrong collaboration skills, ability to communicate concepts effectively with cross-functional team and vendorsThe 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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