Director, Clinical Data Management
O
OraClinical research
Location: Remote - USFull-TimeDirector
Salary not disclosed
Apply NowOpens the employer's application page
Job Details
- Experience
- Minimum of twelve (12) years of experience in clinical trials, with at least ten (10) years in data management, or equivalent education and work experience.
- Required Skills
- Project Management
Requirements
- Hold a bachelor’s degree in applied or life science, or have equivalent education and work experience.
- Have a minimum of 12 years of experience in clinical trials.
- Have at least 10 years of experience in data management.
- Bring extensive clinical data management experience, preferably within a CRO environment.
- Have a record of establishing, directing, and overseeing data management operations in a dynamic environment.
- Have experience with budgeting and forecasting, individual and team leadership, process management, and project management.
- Have expert knowledge and understanding of ICH Guidelines for Good Clinical Practice.
- Have expert knowledge and understanding of Title 21 of the Code of Federal Regulations Part 11.
- Have CDISC CDASH/SDTM training and experience.
- An advanced degree and direct supervisory experience are preferred.
- Ophthalmology experience is a plus.
- Programming, medical coding, and EDC experience with Oracle Clinical Life Sciences Suite or iMedNet are pluses.
Responsibilities
- Oversee day-to-day clinical data management operations.
- Lead the allocated team and manage resources to support departmental growth and team development.
- Serve as a clinical data management subject matter expert in cross-functional initiatives and collaborate with customers.
- Support business development by presenting capabilities to prospective and current clients.
- Manage department and clinical study budgets to achieve or beat targets.
- Liaise with internal and external cross-functional teams, sponsors, and vendors.
- Participate in proposal and contract writing and negotiation.
- Review, write, and update standard operating procedures, work instructions, forms, and templates.
- Develop, analyze, and report departmental performance metrics and KPIs, including trends, root causes, and corrective actions.
- Develop and conduct in-house training and development.
View Full Description & ApplyYou'll be redirected to the employer's site
