Senior Clinical Data Manager
New
F
FortreaClinical Research
Office based or home based in the listed countries in EMEAFull-TimeSenior
Salary not disclosed
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Job Details
- Required Skills
- Risk Management
Requirements
- University/college degree (life science, pharmacy or related subject preferred), or equivalent certification.
- Extensive work experience in clinical data management in lieu of formal qualifications will be considered.
- Proven lead experience across a mix of therapeutic areas, specifically Late Phase (IIb-III) trials.
- Proficiency with EDC systems, ideally Medidata Rave.
- In-depth knowledge of clinical trial processes, biometrics, quality management, and regulatory obligations.
- Strong ability to lead project teams and drive departmental initiatives.
- Excellent oral and written communication and presentation skills.
Responsibilities
- Serve as the technical leader on all data management aspects for project(s) including start-up, maintenance, and completion activities.
- Develop global Data Management Plans and Quality Management Plans.
- Coordinate the development and testing of data management systems, edit/validation checks, and special listings.
- Oversee the technical performance of data review project staff to ensure client satisfaction.
- Collaborate with clinical, programming, statistics, and drug safety teams to support project maintenance and closure.
- Identify and implement solutions to project data management issues using metrics and forecasts.
- Support business development by providing time and cost estimates for prospective clients.
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