Clinical Data Management Director

Job Summary

To support the development of Clinical Data Management Global Standard Operating Procedures, the full-time salaried Clinical Data Management Director will manage project deliverables, oversee team activities, and communicate effectively with clients in a remote work environment.

Key responsibilities

• Support the development of CDM Global Standard Operating Procedures (GSOPs) and prepare study-specific fee estimates for clients
• Provide direction and supervision to CDM team members, ensuring project deliverables are completed on schedule and within budget
• Maintain open communication with internal and external customers, addressing project progress and risks promptly

Required qualifications

• BA/BS in Life Sciences with at least 12 years of experience in Clinical Data Management or a Master's degree with at least 10 years of experience
• Experience with EDC systems, including Medidata Rave and OmniComm TrialMaster
• At least 8 years of direct line management experience
• Knowledge of regional regulations and ICH E6 Good Clinical Practice
• Base background in medical terminology and the drug development process