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