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MED Medtronic Inc - Mounds View, MN
posted about 2 months ago
About the position
The Principal Clinical Research Specialist (CRS) will lead the development and execution of clinical studies, focusing on the assessment of product safety and effectiveness post-market release. This role involves managing complex clinical projects, ensuring compliance with regulatory standards, and providing strategic oversight to clinical teams. The CRS will work independently, driving study management duties and collaborating with key stakeholders to enhance clinical strategies within the Cardiac Ablation Solutions business.
Responsibilities
- Establish and foster relationships with Key Opinion Leaders (KOLs) and internal business partners.
- Lead the development and submission of scientific abstracts, manuscripts, and presentations in compliance with Medtronic SOPs and external guidelines.
- Manage publication activities for assigned projects, ensuring strategic alignment and communication with investigators.
- Create and manage project schedules for deliverables, ensuring compliance with regulatory and corporate standards.
- Evaluate and analyze clinical data to support evidence needs and strategies.
- Develop impactful publication plans and represent the Publications team in congress planning meetings.
- Monitor scientific congresses for abstract deadlines and drive podium presence for Medtronic sponsored research.
- Attend key scientific congresses and manage publication activities, including speaker preparation and session coverage.
- Serve as a liaison between program management, study teams, and leadership.
- Conduct literature searches and reviews to support clinical evaluation research studies.
- Oversee operational aspects of clinical trials in accordance with SOP, GCP, and specific country regulations.
Requirements
- Bachelor's degree
- Minimum of 7 years of clinical research experience OR an advanced degree with 5 years of clinical research experience.
Nice-to-haves
- Ph.D. or MS in engineering, life sciences, or related medical/scientific field
- Clinical Research experience at Medtronic or within a medical device industry
- Experience developing clinical strategies and study design
- Basic understanding of biostatistics and trial design
- Experience in Research and Development (R&D)
- Advanced presentation skills with expertise in literature identification and evaluation
- Project/program management skills/experience
- Demonstrated success in effective interpersonal and communication skills
- Ability to apply different standards related to medical devices/clinical research
- Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials
- Proficient in MS Office applications and project management techniques
- PMP certification or similar project management certification
