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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive expertise in clinical data management, including database architecture design, user acceptance testing, and vendor management. Proficient in establishing data management standards and ensuring compliance with regulatory requirements.
Highest-signal resume keywords
Clinical Data ManagementDatabase Architecture DesignUser Acceptance Testing (UAT)CRO ManagementGood Clinical Practice (GCP)
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Database DesignData CleaningQuery ResolutionReconciliation ActivitiesData Management StandardsSOP DevelopmentTimeline ManagementPerformance OversightRegulatory ComplianceData Quality Management
Soft Skills
Cross-Functional CollaborationProblem SolvingLeadershipCommunicationAccountability
Tools & Technologies
Clinical Database PlatformsElectronic Data Capture (EDC) Systems
Industry Keywords
Clinical StudiesBiostatisticsClinical OperationsData Management CROsPhase 3 Database Lock
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Design and build clinical database architecture for clinical studies, including edit checks, structures, and specifications
- Own end-to-end user acceptance testing for clinical database builds, from test plan development through final sign-off
- Manage data management timelines and deliverables across clinical studies
- Hold vendors accountable to milestones from first patient in through database lock
- Direct selection and ongoing performance oversight of data management CROs and vendors
- Serve as primary escalation point for data quality and timeline issues
- Partner with Biostatistics, Clinical Operations, and Regulatory to align data management plans, CRF design, and database specifications with study protocols
- Establish data management standards, SOPs, and quality control processes
- Lead data cleaning, query resolution, and reconciliation activities
- Represent Data Management in cross-functional program governance and report on database timelines, risks, and trade-offs
Requirements
What you’ll need- Bachelor's degree in life sciences or a related field
- 10+ years of clinical data management experience (12+ years for Director-level candidates)
- Experience taking a database through Phase 3 database lock
- Experience designing clinical databases
- Experience leading user acceptance testing (UAT) execution
- Experience managing CRO and data management vendor relationships, including performance oversight
- Working knowledge of GCP and applicable regulatory requirements for clinical data management
- Preferred: Experience in a small, fast-paced biotech environment
- Preferred: Proficiency with industry-standard clinical database and EDC platforms
Benefits
Comp & perks- Discretionary annual bonus
- Comprehensive medical, dental, and vision benefits
- Life and disability insurance
- 401(k) company match
- Generous paid time off
- Equity
