
Senior Director, Clinical Data Management
Umoja Biopharma
full-time
Posted on:
Location Type: Hybrid
Location: Louisville • Colorado • Washington • United States
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Salary
💰 $247,400 - $305,600 per year
Job Level
Tech Stack
About the role
- Provide strategic and operational leadership for all clinical data management activities across Umoja’s clinical development programs.
- Lead the planning, execution, and oversight of data management activities, clinical systems, and external vendors.
- Ensure the integrity, quality, and regulatory compliance of clinical trial data from protocol development through database lock and regulatory submission.
- Serve as the primary clinical data management lead for assigned clinical trials, with direct accountability for data quality, timeliness, and inspection readiness from protocol development through database lock.
- Actively participate in EDC system configuration and validation activities, including review of database builds, user acceptance testing (UAT), and system change control.
- Ensure clinical trial data is compliant with applicable regulatory requirements, including GCP, ICH, and CDISC standards.
Requirements
- Bachelor’s degree or higher in life sciences, health informatics, computer science, or a related discipline with a minimum of 15 years of experience.
- Significant experience in clinical data management within the biotechnology or pharmaceutical industry, including 8+ years of leadership of data management functions for clinical trials.
- Demonstrated experience overseeing CROs and external vendors delivering clinical data management services.
- Strong working knowledge of clinical trial processes, EDC systems, data standards, and regulatory expectations for clinical data.
- Proven ability to lead teams, manage complex programs, and collaborate effectively in a fast‑paced, matrixed environment.
- Excellent written and verbal communication skills.
Benefits
- Medical, Dental, and Vision plans.
- 401k plan through Fidelity, with a 100% match up to their first 4% deferral.
- Generous Paid Time Off policy.
- Employee commuter benefits.
- Cell phone stipend.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical data managementdata qualityregulatory complianceEDC system configurationuser acceptance testingdatabase lockprotocol developmentdata standardsGCPICH
Soft Skills
leadershipcollaborationcommunicationprogram managementteam managementorganizational skillsproblem-solvingadaptabilityattention to detailinspection readiness