ProClinical is seeking a Head of Clinical Operations for a pharmaceutical company with a robust drug discovery platform which has generated new compounds ready to be launched into preclinical development. This is a permanent position to be based in Paris, France.
- 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 Profile
Skills and Requirements:
- 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
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Sam Walker on +44 203 8569 336 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.