Post Market Clinical Research Specialist I
By Boston Scientific At Marlborough, MA, United States
In collaboration with PMCF management, supports the planning, execution and management of schedules for PMCF activities.
Manages internal and external project materials and timelines.
Bachelor’s degree and 1+ years of related work experience in a clinical/scientific field.
Excellent problem solving and analytical skills.
Strong verbal and written communication skills.
Collaborates to create and maintain documentation (such as plans, protocols, reports) for PMCF surveys, focus groups, and retrospective data reviews.

Are you looking for an exciting opportunity to lead post-market studies and help shape the future of healthcare? We are looking for a Post Market Studies Manager to join our team and help us develop and execute post-market studies to ensure the safety and efficacy of our products. You will be responsible for managing the design, implementation, and analysis of post-market studies and will have the opportunity to collaborate with a diverse team of experts. If you are a strategic thinker with a passion for healthcare, this is the perfect job for you!

Overview The Post Market Studies Manager is responsible for the design, implementation, and analysis of post-market studies to assess the safety, efficacy, and performance of medical devices. This role requires a strong understanding of the medical device industry, regulatory requirements, and clinical research. The Post Market Studies Manager will work closely with internal and external stakeholders to ensure that post-market studies are conducted in accordance with applicable regulations and standards. Detailed Job Description The Post Market Studies Manager will be responsible for the design, implementation, and analysis of post-market studies to assess the safety, efficacy, and performance of medical devices. This role requires a strong understanding of the medical device industry, regulatory requirements, and clinical research. The Post Market Studies Manager will work closely with internal and external stakeholders to ensure that post-market studies are conducted in accordance with applicable regulations and standards.

The Post Market Studies Manager will be responsible for:

• Developing and implementing post-market studies to assess the safety, efficacy, and performance of medical devices
• Designing and executing post-market studies in accordance with applicable regulations and standards
• Analyzing and interpreting data from post-market studies
• Developing and maintaining relationships with internal and external stakeholders
• Ensuring that post-market studies are conducted in a timely and cost-effective manner
• Preparing reports and presentations to communicate study results
Job Skills Required
• Knowledge of medical device industry and regulatory requirements
• Knowledge of clinical research and study design
• Ability to analyze and interpret data
• Excellent communication and interpersonal skills
• Ability to work independently and as part of a team
• Strong organizational and project management skills
• Proficiency in Microsoft Office
Job Qualifications
• Bachelor’s degree in a related field
• 5+ years of experience in medical device industry
• 5+ years of experience in clinical research
• Experience in post-market studies
• Certification in Good Clinical Practice (GCP)
Job Knowledge
• Knowledge of medical device industry and regulatory requirements
• Knowledge of clinical research and study design
• Knowledge of post-market studies
• Knowledge of Good Clinical Practice (GCP)
Job Experience
• 5+ years of experience in medical device industry
• 5+ years of experience in clinical research
• Experience in post-market studies
Job Responsibilities
• Developing and implementing post-market studies