Clinical Data Manager (PR-33320653) München, Deutschland
For an international CRO I am currently seeking freelance support in clinical data management.
Start: ASAP
length: 6 month
volume: 1 FTE
Einsatzort: München / partially remote
- Create and maintain the CRF, documentation and data management guidelines, such as data management plan, data validation guidelines, data tracking guidelines and data entry guidelines
- Review, analyze, and validate data to ensure completeness, consistency, integrity and accuracy based on project specific guidelines including query management
- Apply knowledge of regulations, policies, SOPs, Sponsor guidelines, protocols and/or study specific procedures to control and maintain accurate records
- Assist in or conduct of designing, programming and testing the database (including consistency checks)
- Support the programming of user interfaces (eCRF design, implementation of edit-checks catalogues)
- Generate data views, data listings and data reports
- Perform coding of adverse events and medical data (e.g MedDRA, WHO-DD etc) and manage (S)AE reconciliation
- Management of deliverables sent to sponsors within the agreed quality and timeframe
mehr...
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