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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 Revolutionaries in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.
The Opportunity:
The Clinical Data Associate (CDA) is an individual and team contributor. Support Data Management (DM) Leads and the Clinical Data Science (CDS) department.
Responsibilities:
Support DM Leads in project activities related to ensuring high quality, on-time data management deliverables.
Perform DM tasks as appropriate including: data review and query management to ensure quality.
Perform reconciliation of the clinical database against safety data, laboratory data and other third-party data as appropriate.
Review clinical trial data in accordance with Data Management Plans (DMP), Edit Check Specifications and/or Data Review Guidelines and raise queries to resolve erroneous, missing, incomplete or implausible data.
Generate, resolve, and track queries to address problematic data identified during data review activities and apply proper modification/correction to the database as required.
May run ancillary programs (metrics, special listings, reconciliation discrepancy listings, and reports) used to support the review of clinical trial data.
Review and contribute to the development of DM documents (DMP, eCRF Completion Guidelines, Data Review Guidelines).
May create, review, and/or execute Form and Edit Check Specification User Acceptance Testing (UAT) by creating/reviewing dummy data to evaluate EDC database functionality.
File of DM documentation and DM related administrative tasks as requested, including maintenance of TMF as required.
Demonstrate awareness of project schedules and the importance of achieving deadlines.
Perform other project/department duties as assigned.
Contribute to a professional working environment through exemplifying RevMed Core Values.
Required Skills, Experience and Education:
Minimum of 1 year of experience in Clinical Data Management.
Good oral and written communication skills.
Demonstrate ability to work in a team environment and independently.
Demonstrate good organizational ability and people skills.
Demonstrate time management skill and ability to adhere to project productivity metrics and timelines.
Demonstrate a constructive problem-solving attitude while deadlines focus on time constraints, incomplete information, or unexpected events.
Preferred Skills:
Knowledge of FDA/ICH guidelines and industry standard practices preferred.
Knowledge of drug development process preferred; knowledge of science or a scientific background considered.
Bachelor’s degree in Life Sciences, Computer Sciences, Mathematics, or health-related field preferred
This is a contract position that will be employed through a third-party recruiting agency. The agency will provide the pay range, which will be based on several factors, including job-related skills, experience, market conditions, and relevant education or training.
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 the 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 . For additional information, please contact [email protected]. #LI-Hybrid #LI-AP1
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