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Job Details

Head of Clinical Operations

Company: Key People Limited
Location: Paris
Reference: mc 22967
Closing Date: 23 Feb 18
Type: Permanent
Salary (£): 60,000 - 80,000
Benefits: Plus Stock Options

Job Summary:

Head of Clinical OperationsOur client is conducting a major clinical development program in oncology and inflammatory and neurodegenerative diseases, including 15 ongoing phase 3 studies. ...

Requirements:

Head of Clinical Operations
Our client is conducting a major clinical development program in oncology and inflammatory and neurodegenerative diseases, including 15 ongoing phase 3 studies.
To support the success of its development our client is looking for a

Head of Clinical Operations

Missions
• Plan the clinical development program
• Allocate appropriate resources for clinical studies
• Supervise the smooth running of clinical trials and publications
• Assist in the drafting and validation of clinical trial protocols
• Manage, train and supervise the team of Clinical Research Associates based in France and the United States
• Follow the quality system (SOP) (write, update, validate) and train the staff concerned
• Control SOPs in accordance with company requirements and applicable regulatory requirements (ICH-GCP, EU Directives, CFR)
• Follow the specifications of the companies providing services in clinical monitoring

Profile
• PharmD graduate with ideally 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)
• CTA experience for Submissions to EMA, FDA and National Competent Authorities
• Excellent verbal and written communication skills
• Excellent organizational and managerial skills
• Mastery of IT tools and electronic applications
• Fluent English

• Position based in Paris
• Salary to be defined according to profile and experience

Apply for this job: Head of Clinical Operations

Contact Information:

Address:  Head Office
Catherine House
Adelaide Street
St Albans
Hertfordshire
AL3 5BA
England
Tel:  Tel: 44 (0) 1727 811634
Fax:  Fax: 44 (0) 1727 844838
Website:  Visit Our Web Site

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