Director, Clinical Data Management — Strategic Leader

Ctifacts; Northern (KY); Hybrid; USD 140,000 - 190,000; Full time

Job summary

Ctifacts is seeking an experienced CDM leader to oversee clinical data management activities for complex programs. You will guide the CDM team, ensure compliance with ICH E6 and regulatory requirements, and defend study-specific budgets and staffing against project timelines.

The role emphasizes strong communication with sponsors, risk management, and coordination with senior leadership to ensure high-quality data deliverables and on-time archival through all study phases.

Qualifications

• BA/BS in Life Sciences with at least 12 years of CDM experience or Master's with at least 10 years.
• Experience with EDC systems including Medidata Rave and OmniComm TrialMaster.
• At least 8 years direct line management experience.

Responsibilities

• Support the development of CDM GSOPs and oversee study deliverables.
• Plan and execute resource plans; identify risks and mitigate them.
• Provide supervision, guidance, and mentoring to CDM staff; ensure timely project delivery.

Skills

Leadership

CDM Oversight

Budget Management

Regulatory Knowledge

Communication Skills

Education

BA/BS in Life Sciences

Master's degree in Life Sciences

Tools

Medidata Rave

OmniComm TrialMaster

IBM Clinical Development

Job description

Ctifacts is seeking an experienced CDM leader to oversee clinical data management activities for complex programs. You will guide the CDM team, ensure compliance with ICH E6 and regulatory requirements, and defend study-specific budgets and staffing against project timelines.

The role emphasizes strong communication with sponsors, risk management, and coordination with senior leadership to ensure high-quality data deliverables and on-time archival through all study phases.