Clinical and Scientific Affairs Project Lead (d/f/m)
Come join a fantastic team! As a Clinical and Scientific Affairs Project Lead, you will have cross-functional responsibilities, which require cooperating with various departments such as Product Managers, Regulatory Affairs, R&D, Marketing, Compliance, Legal, Regional Commercial/Sales, Service, Operations/Manufacturing as well as other external partners or authorities.
YOUR RESPONSIBILITIES:
* Select and manage experts and study sites in order to drive, manage and execute research, pre-clinical (animal) and/or clinical studies, including post-market clinical follow-up.
* Author study plans and protocols, and reports, with appropriate literature searches, statistic rationales and methods of assessment, in accordance with intended clinical benefits and performance (study design).
* Ensure operational aspects of the studies are being conducted in accordance with all relevant ethical and government standards, Good Clinical Practices or Good Laboratory Practices, and company's procedures.
* Ensure submissions to regulatory competent authorities and ethics committees/IRBs, as required.
* Up to 50% travel.
YOUR PROFILE
* Degree in Medicine / Medical Engineering/ Pharmacy or other human/clinical/medical science.
* 3+ years’ experience as a Clinical Research Associate, Clinical Project Manager, Study Manager or other related professional role.
* Fundamental knowledge and good understanding of GCPs, clinical trial design, study development and project management.
* Experience in interpreting, preparing, writing, and presenting scientific data and information.
WHAT WE OFFER
* Work and collaboration in an exciting international environment
* A balance between support and autonomy to achieve your own goals in an international environment
* We support employees in their professional and personal development
Do apply online - we are looking forward to your application!
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