Senior Director leading clinical data management across clinical development at Umoja Biopharma, focusing on high-quality compliance and data integrity. Drive collaborative efforts with clinical teams and external vendors.
Responsibilities
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.
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