Clinical Research Scientist
Proclinical is currently recruiting for a Clinical Research Scientist with a pharmaceutical company located in West Chester, PA.
- Work closely with cross-functional teams 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 minimal 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).
- Partner with the Contracts and Payments team to ensure timely execution of all study agreements and corresponding payments for achieved milestones and deliverables.
- Contribute to appropriate interpretation and dissemination of all evidence generated, including abstracts, manuscripts, and Clinical Study Reports (CSR), epidemiology study results and clinical literature.
Skills and Requirements:
- 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 minimal supervision.
- Previous experience developing strategies to generate clinical evidence is strongly preferred.
If you are having difficulty in applying or if you have any questions, please contact Brianna Copeland at 267-297-3280.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.