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  • Clinical Research Scientist Warsaw
  • Actalent in Warsaw, , Poland
  • jobs
  • 1 week ago

jobs description

Clinical Research Scientist - Medical Devices Fully Remote within the European Union The Clinical Research Scientist will be responsible for the development of post-market clinical research strategies of orthopedic devices to support global regulatory and post-market surveillance requirements. Responsibilities include : Work closely with cross-functional teams (Clinical, Medical, Regulatory, R&D, Marketing) to develop post market clinical evidence generation strategies that consider evidence needs for EU Medical Device Regulations (EU MDR). Facilitate clinical evidence reviews with cross functional team to align on clinical evidence strategies, document/track decisions and risks, and write PMCF Plans. Develop and write high quality Post-market Clinical Follow-up (PMCF) plans and reports with mínimal supervision. Support development and drafting of clinical study protocols, registry plans, epidemiology studies, informed consents, investigator brochures, and other study materials where... needed. Review summaries of clinical evidence and PMCF strategies in other areas of the Technical Documentation for accuracy and completeness. This includes the Clinical Evaluation Plan, Clinical Evaluation Report (CEP), Post Market Surveillance Plan and Periodic Safety Update Report (PSUR). Maintain strong understanding of evolving post-market evidence requirements under EU Medical Device Regulation. Where required, foster relationships with surgeons, hospitals and research teams to gain input into study design, evaluate study feasibility, and identify sites for study execution or data collection. Develop strong collaborative relationships with the study core team and others to ensure study progress for assigned projects and that issues are identified and communicated to leaders. We are looking for the following qualifications : A Bachelor's degree in Biological Science or related discipline, with a minimum of 4 years' experience in the medical device industry or healthcare field is required Advanced technical writing skills is required, with demonstrated experience in writing PMCF plans/reports strongly preferred. Strong project management skills required, with demonstrable track record of success managing multiple projects simultaneously with mínimal supervision. Ability to communicate effectively and work with teams is required. Previous experience developing strategies to generate clinical evidence is strongly preferred. Job Title : Clinical Research Scientist Location : Warsaw, Poland Job Type : Contract Aerotek and Actalent Services, an Allegis Group company. Allegis Group AG, Basel, Switzerland. Registration No. CHE-101.865.121. Aerotek and Actalent Services are companies within the Allegis Group network of companies (collectively referred to as "Allegis Group"). Aerotek, Actalent Services, Aston Carter, EASi, TEKsystems, Stamford Consultants and The Stamford Group are Allegis Group brands. If you apply, your personal data will be processed as described in the Allegis Group Online Privacy Notice available on the website. To access our Online Privacy Notice, which explains what information we may collect, use, share, and store about you, and describes your rights and choices about this, please go to the website
Warsaw Poland

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