Hybrid Senior Director, Clinical Data Management

at Umoja Biopharma

• Job title: Senior Director, Clinical Data Management
• Job type: Full Time
• Experience level: Senior
• Salary: $247,400 - $305,600 per year
• Degree requirement: Bachelor's Degree
• Tech skills: Google Cloud Platform
• Location requirements: Hybrid, Louisville, United States

About the role

• 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.
• Generous Paid Time Off policy.
• Employee commuter benefits.
• Cell phone stipend.