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Clinical Research Scientist

Company: Katalyst Healthcares & Life Sciences
Location: Santa Clara
Posted on: November 26, 2022

Job Description:


  • 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.


    • 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.

Keywords: Katalyst Healthcares & Life Sciences, Santa Clara , Clinical Research Scientist, Healthcare , Santa Clara, California

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