Director, Clinical Data Management
About The Position
The Director, Clinical Data Management will be responsible for supporting the development of CDM Global Standard Operating Procedures (GSOPs), preparing and defending study specific fee estimates to clients, presenting CDM capabilities to clients, and communicating project progress, staffing, and resource allocation to Senior Director, Data Management. This role involves planning and executing a resource plan that supports the business, identifying technology needs or other gaps, identifying and communicating risks to the business, and developing solution-oriented approaches to address or mitigate risk. The Director will troubleshoot and resolve critical issues impacting the optimal functioning of the team. They will provide direction to Clinical Data Management (CDM) team members regarding project deliverables, ensuring they are on schedule, meet quality standards, and adhere to project budget from study start-up through archival. Additionally, the role includes providing direct supervision, guidance, and mentoring to CDM staff, encouraging independence and refining their skills. The Director will provide effective and timely feedback to management for performance reviews of project team members. Maintaining open communication with internal and external customers is key, involving contacting sponsor counterparts on an agreed-upon schedule, responding promptly to correspondence, and choosing the appropriate communication method based on urgency and information type, including governance calls with Sponsors. The Director will evaluate team requests by considering factors such as efficiency, quality, budget, resources, and customer relations before committing to an action, and will seek out existing knowledge before developing new methods.
Requirements
- 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
- 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
Responsibilities
- Support the development of CDM Global Standard Operating Procedures (GSOPs)
- Prepare and defend study specific fee estimates to clients
- Present CDM capabilities to clients
- 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
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Director
