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Senior Clinical Research Specialist
MedtronicSenior Clinical Research Specialist managing investigator-sponsored research for Medtronic’s surgical medical-device business. Overseeing clinical operations, compliance, contracting, payments, and device logistics.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing clinical trials within the medical device industry, ensuring compliance with Good Clinical Practice (GCP) and relevant regulations. Proficient in budgeting, invoicing, and stakeholder management while effectively collaborating with cross-functional teams.
Highest-signal resume keywords
Clinical Research ManagementGood Clinical Practice (GCP)Budget ManagementStakeholder ManagementRegulatory Compliance
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Trial RegulationsTrial Master File (TMF) MaintenanceCosting and InvoicingAsset Depreciation TrackingContract NegotiationStudy Policy DevelopmentEuropean Pre-Market StudiesScientific Literature Database ManagementPayment ProcessingOperational Workflow Optimization
Soft Skills
Problem-SolvingOrganizational SkillsProject ManagementAttention to DetailEffective Communication
Tools & Technologies
Clinical Trial Management PlatformsPurchasing Systems
Industry Keywords
Medical Device IndustryInvestigator-Sponsored Research (ISR)Healthcare Professionals (HCPs)ISO 14155CFR 812CFR 50CFR 54
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Oversee investigator-sponsored research from initial review, contracting, and active study management through close-out and publication
- 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) and 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
- Assist 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
What you’ll need- 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 (e.g., CFR 812, CFR 50, CFR 54, ISO 14155)
- Fluent in English, with 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, with high attention to detail
- Professional and compliant stakeholder management skills, including interactions with healthcare professionals (HCPs), 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
Comp & perks- Competitive Salary and flexible Benefits Package
- Wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage
- Short-term incentive called the Medtronic Incentive Plan (MIP)