[Hiring] Senior Clinical Research Specialist @Medtronic

Role Description

The Senior Clinical Research Specialist manages Investigator Sponsored Research (ISR) studies, provides clinical documentation support to the ISR program, and leads continuous improvement of related processes and logistics. This role supports all Surgical business units and operates within a global team, requiring flexibility across global time zones. The role requires a high degree of professionalism, sound judgment, and integrity in all interactions, particularly as it requires 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 studies—from 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.

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.

Qualifications

• Bachelor's 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 pre-market studies and managing multiple clinical research sites.
• Strong knowledge of Good Clinical Practice (GCP), clinical trial regulations, and relevant standards (e.g., CFR 812, CFR 50, CFR 54, ISO 14155).
• Fluent in English, with excellent written and verbal communication skills.
• Proven ability to manage multiple priorities independently and collaborate effectively within cross-functional teams.
• Strong problem-solving, organizational, and project management skills, with high attention to detail.
• Professional and compliant stakeholder management skills, including effective interactions with healthcare professionals (HCPs), investigators, and internal teams.
• Willingness and ability to travel up to 20%.

Preferred Qualifications

• Experience building and maintaining scientific literature databases.
• Experience with payment processes, contracting, and HCP engagement activities.

Benefits

• Medtronic offers a competitive Salary and flexible Benefits Package.
• A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.
• We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
• Pay range: Ireland: 60,800.00 EUR - 91,200.00 EUR | United Kingdom: 50,400.00 GBP - 75,600.00 GBP.
• This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).