Director - Clinical Data Management (REMOTE)
SRG is looking for a Director - Clinical Data Management for our client that is focused on improving the scientific accuracy of analgesic programs. This person will be a key leader on the team who will be responsible for the development and communication of the operational roadmap for the CDM function.
- Coach: Approximately 75% of the time will be spent coaching and managing the team as they manage the studies. This person will need to successfully collaborate with other departments / managers in order to ensure success.
- Player: Approximately 25% of the time will be spent as a player - not managing studies, but jumping in to help as needed.
- Establish CDM processes including SOPs to ensure highest data quality / integrity and regulatory compliance with FDA regulations, GCP, ICH guidelines and Good Clinical DM Practices.
- Lead or direct CDM activities including CRF / eCRF design, validation programming, discrepancy management and database development and production.
- Ensure all CDM documentation are complete, accurate and in an inspection-ready state.
- Ensure vendors, suppliers, & internal staff meet the highest quality standards per SOPs
- Lead strategic decision-making process involving data management issues for ongoing clinical trials
- Provide career development and performance management of individual employees
- Manage escalated conflict resolution through open communication, teamwork, diplomacy, & mediation.
- Maintain current professional knowledge of regulatory requirements and industry best practices in relevant areas of CDM, technology advances, & quality assurance.
- Minimum of 5 years of Clinical Data Management experience
- Minimum 3 years of experience in a leadership position within Clinical Data Management
- Hands - On experience with Veeva Vault required
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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