Senior Director, Clinical Data Management (Hybrid)

CTI Clinical Trial and Consulting Services; Covington (KY); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Hybrid work from home opportunities

Health benefits

Paid parental leave

Tuition reimbursement

Job summary

CTI Clinical Trial and Consulting Services in Covington, KY seeks an experienced Clinical Data Management leader to guide the CDM team from study start-up through archival, ensuring quality, schedule, and budget.

The role requires strong communication, regulatory knowledge (ICH E6), and hands-on management of Medidata Rave, TrialMaster, and IBM Clinical Development; collaboration with sponsors and internal stakeholders is essential.

Qualifications

• BA/BS in Life Sciences with 12+ years in CDM or a Master’s with 10+ years.
• Experience with EDC systems Medidata Rave and OmniComm TrialMaster.
• Minimum 8 years direct line management experience.

Responsibilities

• Support development of CDM GSOPs and ensure adherence to standards.
• Prepare and defend study-specific fee estimates and communicate progress to Senior Director.
• Plan resource needs, identify gaps, and mitigate risks for the CDM team.
• Provide direction, supervision, and mentoring to CDM staff from start-up to archival.
• Deliver timely feedback for performance reviews and maintain sponsor communications.
• Evaluate team requests considering efficiency, quality, budget, resources.

Skills

Communication

CDM knowledge

Project leadership

Independence/Self-motivation

Regulatory knowledge (ICH E6)

Education

BA/BS in Life Sciences

Master’s degree in Life Sciences

Tools

Medidata Rave

OmniComm TrialMaster

IBM Clinical Development

Job description

CTI Clinical Trial and Consulting Services in Covington, KY seeks an experienced Clinical Data Management leader to guide the CDM team from study start-up through archival, ensuring quality, schedule, and budget.

The role requires strong communication, regulatory knowledge (ICH E6), and hands-on management of Medidata Rave, TrialMaster, and IBM Clinical Development; collaboration with sponsors and internal stakeholders is essential.