Clinical Scientist
vor 7 Monaten
The Clinical Scientist EMEA (M/F/d) reports to the Senior Scientist and will responsibly work in three different disciplines: Abiomed’s own studies, investigator-driven clinical and pre-clinical research. The Clinical Scientist (M/F/d) EMEA will be responsible for the development, review, analysis and execution of the company’s European Clinical Affairs and research strategy, with an emphasis on the program of Investigator Sponsored Studies.
**Main Responsibilities**:
Investigator sponsored clinical & pre-clinical research
- Responsible for comprehensive study management for clinical and pre-clinical trials, Chair team meetings for assigned studies ensuring goals and deliverables are clearly defined, and issues, decisions, risks, and actions are appropriately tracked
- Project management of the Investigator sponsored studies including preparation of review meetings, maintaining appropriate documentation of all submitted proposals and providing regular updates
- Establish and maintain a professional and credible image with key physicians and assist in the development of all project-related communication such as research publications and presentations
Abiomed study portfolio
- Execute the European Clinical Affairs Strategy and Research Plan to expand evidence growth through conduction of clinical research, peer-reviewed publication, and effective communication of study results
- Oversee and contribute to development of key study documents including, but not limited to study protocols, protocol amendments, study plans and procedure manuals, project tools, informed consent forms and clinical study reports
- Interface with other departments in regard to execution, quality control and dissemination strategy of trial results
**Qualifications**:
**Job Qualifications**:
- Advanced Degree (M.Sc) in Science, Engineering, or related medical/scientific field, post-graduate training in Basic Science with several years of relevant clinical research experience and experience in clinical trial management
- Completed and up-to-date GCP formation including MDR training
- Solid EU regulatory knowledge including experience with Ethics Committee and Competent Authority submissions in Germany, Switzerland and other EU countries is a plus
- Excellent communication and presentation skills with the ability to effectively engage practicing clinicians, scientists, key opinion leaders, industry executives, etc.
- Strong skills in project management, leading successfully own research projects (from the idea to the publication) and demonstrated success in trial design and execution with diverse research teams
- Excellent organizational, metric-driven project management, and analytical skills required; formal training in epidemiology and/or statistics is preferred
- Self-driven with high level of independence, hands-on mentality; Strong interpersonal, motivational, and team-engaging skills and the ability to work in a fast-paced multicultural, global environment
- Willingness to travel up to 20% to Sites, Conferences and Abiomed offices
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