Manager, Clinical Data Management
Gilead Sciences
full-time
Posted on:
Location Type: Hybrid
Location: Santa Monica • California • United States
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Salary
💰 $123,930 - $160,380 per year
Tech Stack
About the role
- Lead the management of CDM deliverables in coordination with internal and external cross-functional teams
- Lead by providing CDM expertise for data coordination, collection, and cleaning to ensure high quality data
- Perform the execution of end-to-end Data Management activities (e.g., eCRF development, Data Review, study lock)
- Develop and manage data management timelines to meet study goals
- Oversee External Data Management activities by providing project level support
- Anticipate obstacles and difficulties of stakeholders and staff
- Manage the development and finalization of CDM documents for the eTMF
- Review and manage the eTMF for completeness and accuracy
- Serve as a primary point of contact for Data Management activities
- Ensure completeness, accuracy, and consistency of clinical data across all projects
- Responsible for data review, query management, and metric report delivery to study teams
- Coordinate study timelines and database snapshots for analysis and safety review meetings
- Participate in internal audits as well as Health Authority audits
- Participate in the development, review, and implementation of processes affecting CDM
- Proactively provides input to continuous improvement activities within Clinical Data Management
- Demonstrates efficacy in web-based Electronic Data Capture systems (e.g., Medidata Rave)
Requirements
- MS/MA in life sciences or related discipline and 4+ years of experience in Data Management OR
- BS/BA in life science or related discipline and 6+ years of experience in Data Management OR
- High School degree and 10+ years of experience in Data Management
- Experience as independent lead in managing clinical data management deliverables for regulatory filings
- At least 6 years of relevant industry experience with clinical trials
- Experience in Industry Standards Guidelines (e.g., CDISC)
- Strong knowledge of industry-leading EDC tools (e.g., Medidata Rave, Veeva EDC, Oracle, etc.)
Benefits
- company-sponsored medical, dental, vision, and life insurance plans
- discretionary annual bonus
- discretionary stock-based long-term incentives
- paid time off
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
data managementeCRF developmentdata reviewquery managementmetric report deliverydata coordinationdata cleaningclinical data management
Soft Skills
leadershipcommunicationproblem-solvingstakeholder managementorganizational skillsteam collaborationcontinuous improvement