Clinical Research Scientist Jobs

Clinical Research Scientist

The Clinical Research Scientist will be responsible for the development of post-market clinical research strategies of devices to support global regulatory and post-market surveillance requirements.

Responsibilities include:

• Contribute to appropriate interpretation and dissemination of all evidence generated, including abstracts, manuscripts, and Clinical Study Reports CSR , epidemiology study results and clinical literature.
• 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 .
• 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.
• 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 and write high quality Post-market Clinical Follow-up PMCF plans and reports with minimal supervision.
• Maintain strong understanding of evolving post-market evidence requirements under EU Medical Device Regulation.
• Support development and drafting of clinical study protocols, registry plans, epidemiology studies, informed consents, investigator brochures, and other study materials where needed.

Qualified candidates must have:

• Advanced technical writing skills is required, with demonstrated experience in writing PMCF plans / reports
• Strong project management skills required, with demonstrable track record of success managing multiple projects simultaneously with minimal supervision.
• Bachelor's degree in Biological Science or related discipline, with a minimum of 4 years experience in the medical device industry or healthcare field
• Previous experience developing strategies to generate clinical evidence is strongly preferred

SRG ED&I and EEO Statement

• ED&I: Impellam Group and its brands are equal opportunity employers committed to diversity and inclusion.
• EEO Statement: Impellam Group is an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.