Clinical Research Scientist
Kelly is currently seeking an Scientist MDR for a on-going engagement at one of our Global clients in West Chester PA.
This role is a full-time, offering our enhanced benefit package options. As a Kelly employee within this group, you will be eligible for Medical, Dental, 401K and a variety of other benefits options to choose from. This includes paid time off, including holiday, vacation, and sick/personal time unless told otherwise.
The Clinical Research Scientist (MDR) will be responsible for the development of post-market clinical research strategies of orthopedic devices to support global regulatory and post-market surveillance requirements .
- 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 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).
- 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.
- Partner with the Contracts and Payments team to ensure timely execution of all study agreements and corresponding payments for achieved milestones and deliverables.
- Support clinical scientific discussions with internal stakeholders within Clinical, Medical, Regulatory, R&D and Marketing to drive support of the clinical and regulatory strategy, communicate evidence needs.
- Contribute to appropriate interpretation and dissemination of all evidence generated, including abstracts, manuscripts, and Clinical Study Reports (CSR), epidemiology study results and clinical literature.
- Develop a strong understanding of the orthopedic device product portfolio and business needs for clinical evidence to meet regulatory requirements.
- 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 minimal supervision.
- Ability to communicate effectively and work with teams is required.
- Previous experience developing strategies to generate clinical evidence is strongly preferred.
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Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.
About Kelly ®
At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.