Senior Clinical Research Specialist
Medtronic · 2 Locations
Job description
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 95,000 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. A Day in the LifeThe 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. 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 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. 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: 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. Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. Recruitment Fraud Alert We are aware of phishing scams targeting job seekers. Please keep the following in mind: Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses. Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate. If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments. If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at AskHR@medtronic.com. Benefits & CompensationMedtronic 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 / Rango salarial / Intervalo salarial /Fascia retributiva / Tranche de salaire / Gehaltsband / Salaribereik: 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).
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