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Study Manager (Medical Affairs) Basel

Business Type: Clinical Research Organisation
Job Type: Clinical Research, Clinical Study- Trials, Medical Information
Job Level: Not Specified
Position: Contract
Salary: Competitive
Location: Switzerland
Reference: 17885/001
Closing Date: 03/09/12

Our client a major pharmaceutical company, is seeking a Studies Manager for a 6 or 12 month contract in Basel, Switzerland

The Studies Manager will promote the operational excellence of medical affairs studies by managing the development, implementation and revisions of internal SOPs, business guidance and IT support systems. The Studies Manager will create and provide a curriculum of medical affairs training resources for associates to enhance their knowledge and understanding of medical affairs studies. They will also develop and maintain internal networks to optimize communications with key stakeholders while assisting Coordinators of Local Studies in provision of support services for CPO associates.

Developing, maintaining and continuously improve operational standards and procedures to ensure excellence of all types of MASs, interventional, non interventional and investigator initiated trials (IITs)
Verifying processes are in control and compliant by defining, implementing and monitoring metrics and key quality indicators
Support the Coordinators of Local Studies
Develop appropriate corrective and preventive actions (CAPA''s); promote continuous quality improvement activities
Ensure adequate regulatory inspection preparation, management and follow-up

Advanced degree or equivalent education/degree in life science/healthcare
Solid experience in pharmaceutical industry or clinical research
Some people management experience
Excellent understanding and experience of Good Clinical practice (GCP) and regulations pertaining to phase IV studies and investigator initiated trials

Excellent English verbal and written communication
Good problem solving skills including project management
Fforde is acting as a recruitment agency/business.

KEYWORDS: Studies Manager, Medical Affairs, Clinical Study, Clinical Trial, Clinical Research, Life Science, Healthcare, Pharmaceutical, GCP, Basel, Switzerland, Europe

Posted: 06/08/2012 | NPJ Ref: 84697
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