[Remote] Clinical Research Scientist (Device, Ortho)

Note: The job is a remote job and is open to candidates in USA. Red Nucleus is a leading provider of strategic learning and development services for the life sciences industry, dedicated to advancing knowledge to improve lives. The Clinical Research Scientist will develop post-market clinical research strategies for orthopedic devices, ensuring compliance with global regulatory requirements and collaborating with cross-functional teams to generate clinical evidence.

Responsibilities

• 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 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).
• 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.

Skills

• A Master’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
• Clinical expertise in the medical device sector
• Proven experience in conducting clinical studies, registries particularly in the field of orthopaedics
• Strong project management skills required, with demonstrable track record of success managing multiple projects simultaneously with minimal supervision
• Excellent communication skills, including effective interaction with healthcare professionals (HCPs), hospital staff etc.
• Demonstrated experience in writing PMCF plans / reports strongly preferred

Company Overview

• Red Nucleus is a professional training company specializing in marketing learning systems and workshops. It was founded in 1991, and is headquartered in Yardley, Pennsylvania, USA, with a workforce of 501-1000 employees. Its website is http://rednucleus.com.

Company H1B Sponsorship

• Red Nucleus has a track record of offering H1B sponsorships, with 4 in 2024, 1 in 2023, 1 in 2022, 1 in 2021. Please note that this does not guarantee sponsorship for this specific role.