EPM Scientific are currently partnered with a leading global Medical Device company supporting innovative clinical research programmes within the Electrophysiology space. They are urgently seeking a Clinical Research Specialist, reporting to the Clinical R&D Manager, to support the execution and delivery of company-sponsored clinical trials across Europe. This role will work closely with cross-functional stakeholders, investigators, sites, and vendors to ensure studies are conducted efficiently, compliantly, and in line with project timelines. See a summary of the role below:
Role Overview:
- Contract Type: Freelance / Consultant - 1 FTE, Contract until 31 December 2026 (extension possible)
- Language: English (French / Dutch not required)
- Project: Clinical trial execution and site management within Electrophysiology and Medical Devices
Key Responsibilities:
- Support the planning, set-up, execution, and close-out of clinical studies in compliance with ICH-GCP, applicable regulations, and internal procedures.
- Act as a key point of contact for clinical trial sites, investigators, vendors, and cross-functional stakeholders throughout the study lifecycle.
- Assist with the development and maintenance of essential clinical trial documentation, including protocols, informed consent forms, study manuals, monitoring plans, and study reports.
- Coordinate investigational device and study material logistics, tracking, accountability, and site support activities.
- Collaborate with Clinical Research Associates and study teams to support site management activities, monitoring visits, protocol compliance, and data quality.
- Review clinical data, track study milestones and budgets, and support timely delivery of project objectives across allocated studies.
- Contribute to safety-related activities including adverse event reporting, safety documentation, and coordination with relevant internal and external stakeholders where required.
- Maintain strong working relationships with investigators, ethics committees, vendors, and internal teams to ensure successful study delivery.
Requirements:
- Bachelor's, Master's, or PhD in Life Sciences, Biomedical Sciences, Nursing, Biological Sciences, or a related field.
- Minimum 2 years of experience in clinical research, clinical operations, site management, or clinical trial execution.
- Previous CRA experience or hands-on involvement in the management of clinical studies is strongly preferred.
- Good understanding of ICH-GCP, clinical trial processes, and applicable regulatory requirements.
- Experience within medical devices, cardiovascular, electrophysiology, or related therapeutic areas is advantageous.
- Strong organisational, communication, and stakeholder management skills with the ability to work effectively across cross-functional teams.
- Excellent written and verbal English communication skills.
- Willingness to travel across Europe as required by study and project needs.