Director, Clinical Data Management

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

• Support the development of CDM Global Standard Operating Procedures (GSOPs)
• Prepare and defend study specific fee estimates to clients, present CDM capabilities to clients, and communicate project progress, staffing and resource allocation to Senior Director, Data Management
• Plan and execute a resource plan that supports the business; identify technology needs or other gaps; identify and communicate risks to the business and develop solution-oriented approaches to address or mitigate risk; trouble-shoot responsibility by resolving critical issues that impact optimal functioning of the team
• Provide direction of activities of Clinical Data Management (CDM) team members regarding completion of project deliverables to ensure they are on schedule according to quality standards, requirements, and project budget from study start-up through archival
• Provide direct supervision, guidance, and mentoring to CDM staff while encouraging independence and refining skills of staff
• Provide effective and timely feedback to management for performance reviews of project team members on an ongoing basis
• Maintain open communication with internal and external customers by contacting sponsor counterpart on agreed-upon schedule, responding to correspondence promptly and within agreed upon timeframes, and choosing method of communication based on urgency and type of information including governance calls with Sponsors
• Evaluate team requests by considering factors such as efficiency, quality, budget, resources, and customer relations before committing to an action; seek out existing knowledge prior to developing new methods
• Excellent verbal and written communication skills
• Knowledge of Data Management systems including Medidata Rave, OmniComm TrialMaster, and IBM Clinical Development
• Knowledge of regional regulations relative to clinical trial conduct, as well as ICH E6 Good Clinical Practice
• Base background / knowledge regarding medical terminology and drug nomenclature
• Ability to work independently and be self-motivated
• Base background / knowledge of the drug development and clinical research process
• Demonstrated ability to lead project teams

Required Education/Experience:

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

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.