Clinical Affairs Project Manager
Location
EMEA
Posted
1 day ago
Salary
0
Seniority
Lead
No structured requirement data.
Job Description
Clinical Affairs Project Manager
Robeaute
Role Description The Clinical Affairs Project Manager has the responsibility of planning, organizing and executing the GLP preclinical and early clinical studies with Robeauté’s robotic brain biopsy and local drug delivery device, including support of regulatory submissions for clinical studies across geographies, IDE submission to the FDA, reporting to Head of Clinical. - Plan and coordinate the preclinical and clinical studies together with the Head of Clinical and surgeon collaborators. - Preclinical and clinical study design (including GLP animal studies and animal model exploration). - Writing preclinical and clinical protocols. - Preparing documentation for submission to local Ethics Committees, competent authorities in various geographies including to the US FDA (IDE). - Clinical study site contracting. - CRO selection and contracting, including management of both GLP preclinical studies and clinical studies. - Communication and collaboration with surgeon KOLs on study design, protocols and their execution. - Data collection and data management after testing. - Writing of detailed reports after preclinical or clinical use based on the data collected. - Planning and participation in conferences, medical scientific communication and publication support. In parallel, the Clinical Affairs Project Manager is expected to gain detailed knowledge of the clinical applications of Robeauté’s device and connect with and curate surgeon relationships with the goal of growing the surgeon community with mutual respect. The Clinical Affairs Project Manager will collaborate with the technical team that designs hardware and software by giving feedback after any device use in a preclinical or clinical context, on the robot’s performance and in order to develop the platform’s performance with an eye for the global development of the platform. Furthermore, the Clinical Affairs Project Manager will collaborate with Head of Clinical on Medical Affairs management, the representation of Robeauté’s platform at conferences, the creation of a publication pipeline and the medical scientific value communication within the surgeon community. This role is open to candidates based in EMEA locations. Qualifications - MD, Master’s or Ph.D. in a Life Sciences field, Biomedical Engineering and/or M.Eng. and equivalent work experience in relevant areas. - At least 5 years experience in preparation and execution of clinical trials with medical devices, including preclinical (GLP) and/or regulatory submissions (IDE preferred) and subsequent study execution. - Device test experience in lab and clinical environments. - Good written, communication and documentation skills in English required and French preferred. Requirements - Good knowledge of anatomy and physiology and ability to relate to surgeons and the surgeon community. - Ability to communicate Robeauté's product and mission to the surgeon community. - Good ability and predisposition for teamwork as well as ability to work independently. - Strong interdisciplinary understanding of robotics, electronics and control.
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