Genesis Pharma are currently looking for a Head of Clinical Operations 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.

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Company is constantly growing due to great results and winning new projects. They offer competitive flexible packages along with bonuses and provide full visa sponsorship along with relocation packages.

 

Missions

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• Participate in the planning of the clinical development program

• Allocate appropriate resources for the conduct of clinical studies

• Supervise the smooth running of the monitoring activity

• Manage, train and supervise the team of Clinical Research Associates based in France and the United States

• Manage and monitor the performance of Treated Clinical Research Associates in all countries

• Follow the quality system (SOP) (write, update, validate) and train the personnel concerned

• Controlling SOPs in accordance with company requirements and applicable regulatory requirements (ICH-GCP, EU Directives, CFR)

• Follow the specifications of companies providing clinical monitoring

• Ensure the preparation of the Department for Inspections

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Profile

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• Graduate of PharmD, MD or PhD

• Significant experience of at least 7 years in clinical research at a similar position

• In-depth knowledge of clinical development regulations (EMA, FDA)

• Experience Inspections of EMA, FDA and national competent authorities

• Excellent verbal and written communication skills

• Excellent organizational and managerial skills

• Proficiency in computer tools and electronic applications

• Fluent English

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Modalities

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• CDI to be filled as soon as possible

• Based in Paris

• 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: Biometry, Pharma