Clinical and Scientific Affairs Project Lead (f/m/d)

• Selects and manages experts and study sites.
• Drives, manages and executes research, pre-clinical (animal) and/or clinical studies, including post-market clinical follow-up.
• Authors study plans and protocols, with appropriate statistic rationales and methods of assessment, in accordance with intended clinical benefits and performance (study design).
• Ensures 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.
• Ensures submissions to regulatory competent authorities and ethics committees/IRBs, as required.
• On-site driving and executing studies, as required, per specific project.
• Analyses and discusses data and prepares study reports.
• Maintains a high level of professional expertise, staying abreast with scientific literature, product portfolio, and the competitive and healthcare environments.
• Supervises and reviews study data and documentation when collaborating with CROs.
• Drives process improvement initiatives which relate to the described responsibilities.
• Up to 50% travel.

• 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.

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