Covance Clinical Research Manager (M/W) in France
Covance is currently recruiting a Clinical Research Manager (M/W) to be didcated to one of our main client, a well-known pharmaceutical company.
The Clinical Research Manager is accountable for execution and oversight of local operational clinical trial activities and has ownership, oversight and impact on local regulatory and financial compliance, at a country operations level in compliance with ICH GCP and country regulations.
Specifically the role will be responsible for co-ordinating the French and Belgium arms of Global trials. Consequently candidates can be based anywhere in France.
Candidates need strong oncology experience as the majority of studies will be within oncology and ideally have a minimum of 5 years of coordination of oncology studies as a Lead CRA or CTL, for example.
The successful candidate can be 100% home based or office based in Paris.
Education / Qualifications
University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology
In lieu of the above requirement, candidates with minimum of four (4) or more years of relevant clinical research experience in pharmaceutical or CRO industries or experience in a health care setting will be considered
Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries
Thorough understanding of the drug development process
Fluent in French and in English, both written and verbal
Good organizational and time management skills
Working knowledge of ICH, FDA, local regulatory requirements, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start up documents; previous interaction with operational project team and investigative sites preferred.
Excellent communication skills, oral and written.
Self-motivation with the ability to work under pressure to meet deadlines
Works well independently as well as in team environment.
Detail and process oriented
Positive attitude and approach
Interact with internal and external customers with high degree of professionalism and discretion
Good computer skills with good working knowledge of a range of computer packages
Ability to lead and develop junior staff
Flexible and adaptable to a developing work environment
Minimum of 5 years of clinical research experience
Job Number 2018-21103
Job Category Clinical Operations
Position Type Full-Time
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