Umoja Biopharma

Senior Director, Clinical Data Management

Umoja Biopharma

full-time

Posted on:

Location Type: Hybrid

Location: LouisvilleColoradoWashingtonUnited States

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Salary

💰 $247,400 - $305,600 per year

Job Level

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