Senior Clinical Research Specialist

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

📋 Description

• Oversee investigator-sponsored research (ISR) studies from the initial evaluation and contracting phase to active management, closure, and publication.

• Provide support for clinical documentation within the ISR program.

• Drive continuous improvement initiatives across ISR processes and logistics.

• Manage the logistics related to study device shipments, returns, and associated operations.

• Handle budgeting, costing, invoicing, payment processing, and asset depreciation tracking for ISR.

• Facilitate contract negotiations and ensure alignment among internal cross-functional teams.

• Maintain the Trial Master Files (TMF).

• Ensure adherence to Good Clinical Practice (GCP), ISO 14155, regulatory standards, and internal Standard Operating Procedures (SOPs).

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

• Assist in the development and updating of study policies and procedures.

• Support Medtronic-sponsored studies by managing payments, budgets, and workflows for Global Compliance Committee (GCC) approvals.

• Serve as a Subject Matter Expert for purchasing systems, clinical trial management platforms, healthcare professional interactions, and operational workflows.

• Lead efforts to enhance contracting, payment, device logistics, and compliance approval processes.

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

⛳️ Requirements

• Bachelor's degree with over 4 years of clinical research experience, or an advanced degree with a minimum of 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.

• Strong understanding of Good Clinical Practice (GCP), clinical trial regulations, and pertinent standards, including CFR 812, CFR 50, CFR 54, and ISO 14155.

• Proficiency in English.

• Exceptional written and verbal communication abilities.

• Capability to manage multiple priorities autonomously while collaborating effectively with cross-functional teams.

• Strong problem-solving, organizational, and project management capabilities.

• 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% of the time.

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

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

🏝️ Benefits

• Competitive salary along with a flexible Benefits Package.

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