Clinical Research ScientistThe Clinical Research Scientist will be responsible for the development of post-market clinical research strategies of orthopedic devices to support global regulatory and post-market surveillance requirements.
About Red Nucleus
Our purpose is advancing knowledge to improve lives. We succeed by being the premier provider of strategic learning and development, scientific advisory services (commercial, market access, medical affairs), and medical communications solutions for the life sciences industry. Our global team is composed of nearly 1,000 full-time employees whose commitment to creativity, quality, and on-time delivery is unrivaled in our space.At Red Nucleus, we believe in providing a rich working environment that pushes us to innovate in ways that engages our employees to be their best selves. Our culture is about meaningful work, a true sense of community, and fun. We love to celebrate our people and we are proud to have been Internationally recognized as a Great Place to Work.
Responsibilities Include
- 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.
Qualifications
- 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.
