Clinical Trial Manager (Remote)
Location: UK Remote (with occasional global travel)
Salary: Competitive + Benefits
Job Type: Full-time, Permanent
CY Partners are recruiting for an experienced Clinical Trial Manager to join an innovative organisation operating within the diagnostics and life sciences sector. This is an exciting opportunity to take ownership of the operational delivery of international clinical performance studies supporting the development and regulatory approval of cutting-edge in vitro diagnostic (IVD) products.
Working remotely, you will lead multi-site clinical studies from initiation through to close-out, ensuring delivery against timelines, budgets and quality standards while maintaining compliance with GCP, IVDR and FDA requirements.
The Role
As Clinical Trial Manager, you will be the operational lead for assigned clinical performance studies, coordinating clinical sites, CROs and external vendors to ensure successful study execution. You will work closely with clinical, regulatory, laboratory and programme management teams to deliver inspection-ready studies that generate high-quality clinical evidence.
Key Responsibilities
- Lead the end-to-end operational delivery of clinical performance studies, including study start-up, site activation, recruitment, monitoring coordination, close-out and archiving.
- Develop and maintain study plans, timelines, milestones and operational trackers.
- Manage study RAID logs, protocol deviations, action logs, decision logs and change control processes.
- Implement recovery plans where recruitment or study delivery falls behind schedule.
- Build and maintain strong relationships with clinical sites, investigators and study staff.
- Coordinate monitoring activities and manage CRA resources using a risk-based approach.
- Oversee CROs and third-party vendors, ensuring performance expectations and project milestones are achieved.
- Support site contracting activities and budget tracking alongside internal stakeholders.
- Ensure studies are conducted in compliance with GCP, IVDR, FDA requirements and internal quality management systems.
- Maintain inspection-ready Trial Master Files (TMFs) throughout the study lifecycle.
- Support audit and inspection readiness activities, including CAPA implementation where required.
- Coordinate clinical data flow, query resolution and documentation activities with sites and vendors.
- Provide accurate study status updates to internal and external stakeholders.
- Collaborate with laboratory and analytical teams to align sample logistics, kit readiness and operational requirements.
About You
Essential Requirements
- Demonstrated clinical trial or clinical study management experience within IVD, diagnostics, medical devices, life sciences or another regulated environment.
- Strong working knowledge of Good Clinical Practice (GCP) and clinical evidence generation supporting regulatory submissions.
- Experience managing multi-site clinical studies, including site start-up, monitoring oversight, issue management and close-out activities.
- Proven experience maintaining inspection-ready documentation, including TMFs and study records.
- Strong stakeholder management skills with the ability to coordinate sites, CROs, vendors and internal teams.
- Excellent organisational and project management capabilities.
- Experience using project management and collaboration tools such as Smartsheet, MS Project, Teams or SharePoint.
Desirable Experience
- Experience supporting clinical evidence packages for IVDR (2017/746) and/or FDA submissions.
- Knowledge of EDC systems and clinical data management processes.
- PRINCE2, PMP, AgilePM or equivalent project management certification.
- ACRP, SoCRA or similar clinical research certification.
What's on Offer?
- Fully remote UK-based position.
- Opportunity to work on innovative diagnostic technologies with global impact.
- Exposure to international, multi-site clinical studies.
- Collaborative and supportive working environment.
- Competitive salary and benefits package.
- Opportunities for professional development and career progression.
Additional Information
This role will require occasional travel to clinical sites and project meetings globally as business needs dictate.
If you are an experienced Clinical Trial Manager looking for an opportunity to lead complex clinical studies in a growing and innovative environment, we'd love to hear from you.
Apply today or contact CY Partners for a confidential discussion.