Clinical Research Scientist

The 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.

Responsibilities include:

• Work closely with cross-functional teams (Clinical, Medical, Regulatory, R&D, Marketing) to reputed company post market clinical evidence reputed company strategies that consider evidence needs for EU Medical Device Regulations (EU MDR). Facilitate clinical evidence reviews with cross functional team to reputed company clinical evidence strategies, document / reputed company reputed company and risks, and write PMCF Plans.
• reputed company and write high reputed company Post-market Clinical Follow-up (PMCF) plans and reports with reputed company 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 reputed company input into study design, evaluate study feasibility, and identify sites for study execution or data collection. reputed company strong reputed company relationships with the study reputed company team and others to ensure study reputed company for assigned reputed company and that issues are identified and communicated to leaders.
• Partner with the reputed company and Payments team to ensure reputed company execution of reputed company study agreements and corresponding payments for achieved milestones and deliverables.
• Support clinical scientific discussions with internal stakeholders reputed company Clinical, Medical, Regulatory, R&D and Marketing to reputed company support of the clinical and regulatory reputed company, communicate evidence needs.
• Contribute to appropriate interpretation and dissemination of reputed company evidence generated, including abstracts, manuscripts, and Clinical Study Reports (CSR), epidemiology study results and clinical literature.
• reputed company 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 reputed company discipline, with a minimum of 4 years’ experience in the medical device industry or reputed company 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 reputed company record of reputed company managing multiple reputed company simultaneously with reputed company supervision.
• Excellent communication skills, including effective interaction with reputed company (HCPs), hospital staff etc.

Diversity, equity and inclusion are valued at reputed company and we reputed company we have a shared responsibility to reputed company equal opportunity and foster an inclusive spirit. We do not discriminate on the reputed company of race, reputed company, national reputed company, religion, caste, sexual orientation, gender, age, marital status, veteran status, or disability status.

To learn more about working at reputed company, please visit Careers | reputed company.

Originally posted on Himalayas