Senior Clinical Research Specialist

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain restore health and extend life. Our 95000 employees work across more than 150 countries to put patients first developing innovative medical technologies that improve the lives of 72 million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose growth and impact.

In this exciting role as a Sr Clinical Research Specialist (CRS) in our Surgical Operating Unit (OU) you will manage Investigator-Sponsored Research (ISR) studies provide clinical documentation support and lead continuous improvement across ISR processes and logistics. Operating within a global team this role supports all Surgical business units and requires flexibility across time zones alongside a high degree of professionalism sound judgment and integrity when engaging with healthcare professionals (HCPs) investigators and external research partners.

Most of your time will be spent driving the operational execution financial administration and oversight of ISR studiesfrom review and contract negotiation through close-out and publication. You will work with centralized internal teams and global stakeholders to maintain Trial Master Files (TMF) ensure GCP and regulatory compliance and optimize workflows spanning payments device logistics and GCC approvals.

Our Surgical OU brings together three Business Units to deliver high-quality clinical evidence from concept to commercialization. As part of this dynamic environment you will also serve as a Subject Matter Expert for clinical and purchasing systems support Medtronic-sponsored study activities and act as the European representative on the global ISR Council of Expertise.

Responsibilities may include the following and other duties may be assigned:

• End-to-End ISR Management:
  Oversee investigator-sponsored research from initial review contracting and active study management through close-out and publication.
• Device & Logistics Execution:
  Manage study device shipments returns and associated logistics for assigned studies.
• Financial Administration:
  Handle ISR costing budgeting invoicing payment processing and asset depreciation tracking.
• Contracting & Stakeholder Alignment:
  Coordinate contract negotiations and align internal cross-functional stakeholders to ensure timely execution.
• Quality & Audit Readiness:
  Maintain Trial Master Files (TMF) and ensure compliance with GCP ISO 14155 regulatory requirements and internal SOPs.
• Global Representation & Policy Support:
  Serve as the European representative on the global ISR Council of Expertise and help develop/update study policies and procedures.
• Sponsor Study Support:
  Assist Medtronic-sponsored studies with payments budget management and Global Compliance Committee (GCC) approval workflows.
• Systems & Process SME:
  Act as Subject Matter Expert for purchasing systems clinical trial management platforms HCP interactions and operational workflows.
• Process Improvement:
  Lead initiatives to optimize contracting payment device logistics and compliance approval processes.
• Cross-Functional Collaboration:
  
  Partner closely with internal teams and present key updates during Medical Evidence team meetings.

Required Knowledge and

Experience:

• Bachelors degree with 4 years of clinical research experience or an advanced degree with 2 years of clinical research experience.
• 5 years of experience managing or supporting clinical trials within the medical device industry including experience working on European…