Clinical Research Scientist

Job not on LinkedIn

🕒 2 days ago

🇺🇸 United States – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

🦅 H1B Visa Sponsor

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👻 Ghost score 10%

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Red Nucleus

WebsiteLinkedInAll Job Openings

501 - 1000 employees

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

Healthcare • Consulting • Manufacturing

Red Nucleus is a company specializing in healthcare and life sciences services, offering a wide range of advisory and scientific services. With over three decades of experience, they provide solutions across the life sciences product life cycle, aiming to improve health outcomes. Their services include market access and commercialization, medical communications, and learning and development. Red Nucleus also offers products like DirectusPRO and iTakeControl. They focus on supporting strategic and operational challenges in healthcare through their expertise in areas like Quality, Clinical, Safety, Regulatory, and Medical Affairs. The company employs a team of over 700 members dedicated to advancing knowledge and improving lives.

📋 Description

• Develop post-market clinical research strategies for orthopedic devices to support global regulatory and post-market surveillance requirements • Collaborate with Clinical, Medical, Regulatory, R&D, and Marketing teams on post-market clinical evidence generation strategies considering EU MDR evidence needs • Facilitate clinical evidence reviews, align strategies, document and track decisions and risks, and write PMCF Plans • Develop and write PMCF plans and reports with minimal supervision • Support clinical study protocols, registry plans, epidemiology studies, informed consents, investigator brochures, and other study materials • Review clinical evidence summaries and PMCF strategies in technical documentation, including CEP, CER, PMS Plan, and PSUR • Build relationships with surgeons, hospitals, and research teams to support study design, feasibility evaluation, site identification, and data collection • Collaborate with study core teams to ensure project progress and communicate issues to leaders • Partner with Contracts and Payments to execute study agreements and payments for milestones and deliverables • Support clinical scientific discussions with internal stakeholders to advance clinical and regulatory strategy and communicate evidence needs • Interpret and disseminate evidence through abstracts, manuscripts, CSRs, epidemiology study results, and clinical literature • Develop understanding of the orthopedic device portfolio and clinical evidence business needs

🎯 Requirements

• A Master’s degree in Biological Science or related discipline is required • Minimum of 4 years’ experience in the medical device industry or healthcare field • Advanced technical writing skills • Demonstrated experience writing PMCF plans/reports strongly preferred • Clinical expertise in the medical device sector • Proven experience conducting clinical studies and registries, particularly in orthopaedics • Strong project management skills, with a demonstrable track record managing multiple projects simultaneously with minimal supervision • Excellent communication skills, including effective interaction with healthcare professionals and hospital staff

🏖️ Benefits

• Equal opportunity and inclusive workplace commitment • Non-discrimination on the basis of race, color, national origin, religion, caste, sexual orientation, gender, age, marital status, veteran status, or disability status