Senior Clinical Research Specialist

This is a fully remote position, open to applicants in United Kingdom, +1 more country.

📋 Description

• Supervise investigator-sponsored research from the initial review phase, through contracting, active study management, and concluding with close-out and publication.

• Oversee the shipment and return of study devices along with managing related logistics.

• Manage ISR costing, budgeting, invoicing, payment processing, and tracking of asset depreciation.

• Facilitate contract negotiations and synchronize internal cross-functional stakeholders.

• Maintain Trial Master Files (TMF) and ensure adherence to GCP, ISO 14155, regulatory standards, and internal SOPs.

• Act as the European representative on the global ISR Council of Expertise.

• Contribute to the development and updating of study policies and procedures.

• Support Medtronic-sponsored studies with payment processing, budget management, and Global Compliance Committee (GCC) approval workflows.

• Serve as a Subject Matter Expert for purchasing systems, clinical trial management platforms, HCP interactions, and operational processes.

• Drive initiatives aimed at optimizing contracting, payment, device logistics, and compliance approval workflows.

• Collaborate with internal teams and provide key updates during Medical Evidence team meetings.

⛳️ Requirements

• A bachelor's degree with over 4 years of clinical research experience, or an advanced degree with at least 2 years of clinical research experience.

• More than 5 years of experience in managing or supporting clinical trials within the medical device sector.

• Experience with European pre-market studies and the management of multiple clinical research sites.

• In-depth knowledge of Good Clinical Practice (GCP), clinical trial regulations, and relevant standards (e.g., CFR 812, CFR 50, CFR 54, ISO 14155).

• Proficient in English, with outstanding written and verbal communication abilities.

• Capability to independently manage multiple priorities while collaborating effectively within cross-functional teams.

• Excellent problem-solving, organizational, and project management skills, with a keen attention to detail.

• Professional and compliant stakeholder management abilities, including interactions with healthcare professionals (HCPs), investigators, and internal teams.

• Willingness and capacity to travel up to 20% of the time.

• Preferred: Experience in building and maintaining scientific literature databases.

• Preferred: Familiarity with payment processes, contracting, and HCP engagement activities.

🏝️ Benefits

• Competitive Salary and a flexible Benefits Package.

• A diverse array of benefits, resources, and competitive compensation plans crafted to support you at every stage of your career and life.

• Short-term incentive known as the Medtronic Incentive Plan (MIP).