Clinical Research Scientist

This is a fully remote position, open to applicants in United States.

📋 Description

• Formulate post-market clinical research strategies for orthopedic devices to meet global regulatory and post-market surveillance obligations.

• Collaborate with Clinical, Medical, Regulatory, R&D, and Marketing teams to develop post-market clinical evidence generation strategies that address EU MDR evidence requirements.

• Facilitate the review of clinical evidence, align strategies, document and monitor decisions and risks, and create PMCF Plans.

• Independently develop and compose PMCF plans and reports with minimal oversight.

• Assist in creating clinical study protocols, registry plans, epidemiological studies, informed consents, investigator brochures, and other relevant study materials.

• Evaluate clinical evidence summaries and PMCF strategies within technical documentation, including CEP, CER, PMS Plan, and PSUR.

• Establish relationships with surgeons, hospitals, and research teams to aid in study design, feasibility assessment, site identification, and data collection.

• Collaborate with study core teams to ensure project advancement and communicate any issues to leadership.

• Work alongside Contracts and Payments to implement study agreements and manage payments for milestones and deliverables.

• Facilitate clinical scientific discussions with internal stakeholders to enhance clinical and regulatory strategies and convey evidence needs.

• Analyze and share evidence through abstracts, manuscripts, CSRs, epidemiological study findings, and clinical literature.

• Cultivate an understanding of the orthopedic device portfolio and the clinical evidence needs of the business.

⛳️ Requirements

• A Master’s degree in Biological Science or a related field is essential.

• At least 4 years of experience in the medical device industry or healthcare sector is required.

• Advanced skills in technical writing are necessary.

• Prior experience in drafting PMCF plans/reports is highly preferred.

• Clinical expertise within the medical device industry is a must.

• Proven experience in conducting clinical studies and registries, especially in orthopaedics, is required.

• Strong project management abilities, with a proven history of managing multiple projects concurrently with limited supervision.

• Outstanding communication skills, including the ability to effectively engage with healthcare professionals and hospital personnel.

🏝️ Benefits

• Commitment to an equal opportunity and inclusive workplace.

• Non-discrimination based on race, color, national origin, religion, caste, sexual orientation, gender, age, marital status, veteran status, or disability status.