Clinical Research Scientist
Company: Katalyst Healthcares & Life Sciences
Location: Santa Clara
Posted on: November 26, 2022
- 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
- Review summaries of clinical evidence and PMCF strategies in
other areas of the Technical Documentation for accuracy and
- 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
- 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
- Develop a strong understanding of the orthopedic device product
portfolio and business needs for clinical evidence to meet
- 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
- 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
- Previous experience developing strategies to generate clinical
evidence is strongly preferred.
Keywords: Katalyst Healthcares & Life Sciences, Santa Clara , Clinical Research Scientist, Healthcare , Santa Clara, California
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