Senior Clinical Research Specialist
Employment Information
Report this job
Job expired or something wrong with this job?
Job Description
Senior Clinical Research Specialist managing investigator-sponsored research for Medtronic’s surgical medical-device business. Overseeing clinical operations, compliance, contracting, payments, and device logistics.
Responsibilities:
- 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:
- 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:
- 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)
Similar Jobs
Clinical Research Associate
Clinical Research Associate monitoring clinical trials for ICON, a global healthcare intelligence and clinical research organisation. Ensuring protocol compliance, data integrity, patient safety, and high-quality study data.
Clinical Data Manager
Clinical Data Manager leading clinical trial data management and data quality for ICON, a global clinical research organisation. Owning study data from start-up through database lock and close-out.
Clinical Research Associate II
Clinical Research Associate II monitoring diagnostic clinical studies for Karius, a genomic infectious-disease diagnostics company. Managing investigative sites, data verification, compliance, and monitoring visits.
Senior Clinical Research Associate
Senior Clinical Research Associate monitoring clinical trials for ICON, a global healthcare intelligence and research organization. Ensuring protocol compliance, data integrity, site performance, and regulatory standards.
Head of Clinical Research
Head of Clinical Research leading grants, publications, and research governance for CSD’s autism and developmental-services network. Advancing evidence-based ABA, telehealth, and technology-enabled care.
Clinical Research Associate II
Clinical Research Associate II advancing AbbVie’s innovative medicines through clinical trial site management. Monitoring sites, ensuring compliance, data integrity, recruitment, and patient safety.
Senior Biostatistician, Clinical Trial Experience Required
Senior Biostatistician leading clinical-trial design, programming, and statistical reporting for CTI, a global full-service clinical research CRO. Overseeing SDTM/ADaM analyses, regulatory submissions, and project delivery.
Clinical Research Associate, U.S. Expert Network
Clinical Research Associate joining Alcedis, a Germany-based clinical research organization expanding in the United States. Supporting oncology and Alzheimer’s clinical trials through flexible, project-based monitoring assignments.
Senior Clinical Research Associate
Senior Clinical Research Associate advancing AbbVie’s innovative medicines through site monitoring and clinical trial execution. Partnering with investigators and study teams to ensure compliance, patient safety, data integrity, and recruitment success.
Senior Manager, Clinical Trial Management
Senior clinical trial manager overseeing pharmaceutical and device studies for Precision Medicine Group. Leading feasibility, monitoring, compliance, recruitment, vendors, and clinical teams remotely in the United States.
Senior Biostatistician
Senior Biostatistician leading observational studies using real-world clinico-genomic cancer data for AACR Project GENIE. Designing analyses, programming in R, and translating findings into publications.
Principal Biostatistician
Principal Biostatistician leading statistical strategy, analyses, and regulatory delivery for Fortrea’s global clinical-trial programs. Mentoring statisticians and advising multidisciplinary teams across complex CRO studies.
Clinical Research Manager
Clinical Research Manager overseeing ophthalmology trials for TFS HealthScience, a global contract research organization. Coordinating CRAs, sites, sponsors, monitoring quality, and study delivery across Poland, Spain, and Italy.
Clinical Research Lead
Site Engagement Liaison building clinical trial site relationships for ICON, a global healthcare intelligence and clinical research organisation. Supporting study compliance, engagement strategies, and site performance.
Senior Clinical Research Associate
Senior Clinical Research Associate managing oncology and complex clinical trials for ClinChoice, a global full-service CRO. Conducting site monitoring, data verification, safety reporting and study closeout.
Senior Clinical Research Associate
Senior Clinical Research Associate overseeing oncology Phase I trials for ICON, a global clinical research organisation. Managing investigative sites, monitoring data integrity, and ensuring patient safety and inspection readiness.
In-House Clinical Research Associate II
In-house Clinical Research Associate supporting site management and data-quality activities for Worldwide Clinical Trials, a global contract research organization. Coordinating clinical-study documentation, monitoring support, queries, recruitment, and site communications.
Senior Clinical Research Associate – CNS
Senior Clinical Research Associate managing CNS clinical trial sites for Worldwide Clinical Trials, a global CRO. Overseeing study start-up, site maintenance, compliance, and closeout activities.
Clinical Research Associate 2
Clinical Research Associate monitoring clinical trials for ICON, a global healthcare intelligence and clinical research organisation. Ensuring protocol compliance, data integrity, patient safety, and high-quality study delivery.
Senior Clinical Research Associate – Oncology
Senior Clinical Research Associate monitoring oncology trials for ICON, a global clinical research organisation. Conducting site visits, ensuring compliance, and overseeing patient safety, data quality, and site performance.