Director, Clinical Data Management

Essential Functions:

• 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

Competencies:

• 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