Clinical Research Scientist
I am currently partnering with a leading medical device company in the greater Philadelphia area to secure a clinical research scientist to support their EU MDR project on a 12 month contract.
This is a remote role with office visits once per quarter when safe to do so. This role pays between $50-60 per hour plus full suite of W2 benefits plus two weeks PTO.
- Support the development of post market clinical evidence generation strategies that consider evidence needs for EU MDR.
- Facilitate clinical evidence reviews with cross functional team to align on clinical evidence strategies and activities.
- Develop and write high quality 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 including CEP, CER, and 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.
Qualifications and Experience:
- A Bachelor's degree in Biological Science or related discipline, with a minimum of 4 year's experience in the medical device industry or healthcare field is required. Senior positions require at least 8-10 years of experience.
- Advanced technical writing skills is required, with demonstrated experience in writing clinical study protocol /reports strongly preferred.
- Strong project management skills required, with demonstrable track record of success managing multiple projects simultaneously with minimal supervision.
- Ability to communicate effectively and work with teams is required.
- Previous experience developing strategies to generate clinical evidence is strongly preferred.
This is an exciting long-term opportunity with a global leading medical devices manufacturer. If this position is of interest to you, I am looking forward to hearing from you.
Sthree US is acting as an Employment Business in relation to this vacancy.