Your role
As Clinical & Medical Affairs Manager, you are in charge of the coordination of the operational Clinical activities.
You are also the point of contact for the Key Opinion Leaders for the roll out of the Clinical and Medical strategy.
Your responsibilities
Be the key strategic medical lead for the clinical trials
Further company’s clinical development program by assisting in the design and conduct of clinical trials including the drafting of protocols and amendments
Be the Medical Expert (“Medical Monitor”) for ongoing clinical trials which includes being readily available to advise on trial related medical questions or problems during the conduct of the trial
Perform monitoring in multiple investigation sites, including site initiation, training, monitoring and close-out activities
Assist in medical review, assessment and interpretation of clinical and safety data to ensure that the data are correct and presented with the appropriate medical interpretation
Provide active input in the development/update of Investigator Brochure (IB), Risk Management Plans, Statistical Analysis Plan, Clinical Study Reports
Contribute to the writing, editing and submissions of articles for publication in peer-reviewed international scientific and medical journals
The successful candidate will have the following skills, knowledge, experience and qualities:
You own a Master or Phd degree in Sciences (Biomedical engineering, Biomedical Sciences, etc.)
You have minimum of 5 years of clinical research experience
You have excellent vendor management skills.
You have developed expertise in collaborating with KOL’s.
You have good ability to write and edit technical documents, such as synopsis, protocols and other trial-related documents.
You are a good communicator, combining diplomacy and assertiveness both with external stakeholders and with the internal team.
You have proven problem-solving skills.
You have an entrepreneurship mindset and you are result-oriented.
You have a strong team spirit.
You are fluent in French and English (excellent oral and written communication).
Our client offers a friendly, dynamic and entrepreneurial start-up atmosphere and team. You would have the chance to get involved in the company evolution and in the full chain of development, from specifications to clinical investigations and market and, ultimately, help improve people’s life.
Our client offers a full-time open-ended contract and good salary package and flexible advantages.
