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Senior Manager Clinical Data Management
- Permanent
- Data Management
- Germany
This vacancy has now expired. Please see similar roles below...
Proclinical are recruiting a Senior Manager Clinical Data Management for a biotech organisation. This role is on a permanent basis with the ability to work remotely from anywhere in Germany.
Responsibilities:
- Monitor clinical data management actions.
- Arrange, perform and supervise clinical data management actions rendering to the company's method and standards.
- You will validate or conduct sponsor user acceptance testing a clinical database.
- The ideal candidate will serve as the amin point of contact for partners, and sub-contractors on data management deliverables and actions.
- Recognise the needs for the development and amendments of the clinical database in collaboration with the trial team.
- Offer assistance for sponsor clinical data medical evaluation.
- Raise unresolved data or compliance problems to the functional manager, work with CRO managers, partners, vendors and internal team members for resolutions.
- Guarantee services and quality meet agreed specifications per the DMP and company quality standards.
- Contribute to the development and execution of new technology or tool.
- Other duties may be assigned to this role.
Key Skills and Requirements:
- Educated to a degree level in a natural/life science field or past involvement working within a CRO/biotech/pharmaceutical organisation in a clinical data management role.
- At least 5-7 years of experience working within clinical data management with familiarity in oversight of DM actions as a lead and DM project management.
- Expertise on global regulations such as ICH-GCP, for the performance of clinical research projects and familiarity with clinical database systems and procedures.
- Fluency in the English language.
- Communication skills both verbally and in writing.
- Computer literacy.
- Acquaintance with at least 1 clinical data management system: Medidata, OCRDX, Inform, etc.
- Capable of assuming own accountability.
- Ability to resolve issues.
- An organised individual with a high attention to detail.
- Works well independently with the ability to take the initiative.
- Works well in a team.
If you are having difficulty in applying or if you have any questions, please contact Heidi Hennigan at +44 203 854 1033.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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