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Clinical Quality Assurance Manager

Paris, France

Reference number: CQAM1

Genesis Pharma are currently looking for a Clinical Quality Assurance Manager to join a leading Pharmaceutical company based in Paris.  Full time position with fantastic benefits available to all employees from day 1 and high competitive salaries.

 

Missions

 

  • Set up, monitor and follow up on our plan to audit clinical systems and sites worldwide.

  • Coordinate site audit activities with external audit partners.

  • Manage the preparation of audits and inspections. Implement and follow up with all internal and external stakeholders the implementation of the resulting action plans.

  • Participate in the writing of essential clinical trial documents, leading in updating procedures.

  • Develop the training required for the proper conduct of our studies in compliance with regulations and PCBs.

  • Quality internal consultant for our teams mainly monitors and project managers.

 

Profile

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  • Holds a Bac +4/5 scientific degree and a training in Clinical Research

  • Expert in Good Clinical Practice ref. ICH and FDA BPC guidelines

  • Successful experience in monitoring clinical studies in a pharmaceutical or CRO laboratory

  • Five years minimum clinical experience

  • Minimum one year as clinical site auditor

  • Control of the regulatory environment for clinical trials

  • Fluent English

 

Modalities

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  • CDI to be filled as soon as possible

  • Post based in Paris, with some possible displacements

  • Salary to be defined according to profile and experience

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To apply for this role, find out more about this or other roles, please forward your most up to date CV to Natalie.hough@genesisglobalgroup.eu and a member of the Genesis Pharma team will be in contact as soon as possible.

 

 

TAGS: Quality Assurance

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© 2015 by Genesis Global Group.

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