Senior Clinical Research Specialist
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Job Description
Senior Clinical Research Specialist managing investigator-sponsored medical-device studies for Medtronic. Overseeing clinical compliance, contracts, budgets, logistics, and global research stakeholders.
Responsibilities:
- Manage investigator-sponsored research (ISR) studies from initial review, contracting, and active study management through close-out and publication
- Provide clinical documentation support to the ISR program
- Lead continuous improvement across ISR processes and logistics
- Manage study device shipments, returns, and associated logistics
- Handle ISR costing, budgeting, invoicing, payment processing, and asset depreciation tracking
- Coordinate contract negotiations and align internal cross-functional stakeholders
- Maintain Trial Master Files (TMF)
- Ensure compliance with GCP, ISO 14155, regulatory requirements, and internal SOPs
- Serve as the European representative on the global ISR Council of Expertise
- Help develop and update study policies and procedures
- Support Medtronic-sponsored studies with payments, budget management, and Global Compliance Committee (GCC) approval workflows
- Act as Subject Matter Expert for purchasing systems, clinical trial management platforms, HCP interactions, and operational workflows
- Lead initiatives to optimize contracting, payment, device logistics, and compliance approval processes
- Partner with internal teams and present key updates during Medical Evidence team meetings
Requirements:
- 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
- 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, including CFR 812, CFR 50, CFR 54, and ISO 14155
- Fluent in English
- Excellent written and verbal communication skills
- Ability to manage multiple priorities independently and collaborate effectively within cross-functional teams
- Strong problem-solving, organizational, and project management skills
- High attention to detail
- Professional and compliant stakeholder management skills, including interactions with healthcare professionals, investigators, and internal teams
- Willingness and ability to travel up to 20%
- Preferred: Experience building and maintaining scientific literature databases
- Preferred: Experience with payment processes, contracting, and HCP engagement activities
Benefits:
- Competitive salary and flexible Benefits Package
- Short-term incentive called the Medtronic Incentive Plan (MIP)
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