Senior Clinical Trial Associate

Hlx Life Sciences; Greater London; Hybrid; GBP 65,000 - 85,000; Full time

Benefits offered by this job

Opportunity to work within an innovative environment

Exposure to cutting-edge clinical development programs

Job summary

A leading biotechnology firm in Greater London is seeking a Senior Clinical Research Associate for a 6-month contract. The candidate will support the operational delivery of Phase I–III clinical trials, ensure TMF quality, and collaborate with various teams for study execution. With at least 5 years of experience in clinical operations and expertise in managing clinical trial documentation, this role offers exposure to innovative cell therapy programs in a hybrid working environment.

Qualifications

• Minimum 5 years’ experience as a Clinical Trial Associate or in a comparable role.
• Strong experience in Phase I–III clinical trials.
• Experience in biotechnology environments is preferred.
• Exposure to multiple complex therapeutic areas and global clinical trial operations
• Strong understanding of clinical trial documentation, TMF management and regulatory processes
• Excellent organisational skills with the ability to manage multiple studies and priorities simultaneously
• Strong communication skills and ability to work effectively within cross-functional clinical teams

Responsibilities

• Support operational delivery of Phase I–III clinical trials.
• Maintain and oversee Trial Master File (TMF) quality.
• Coordinate trial documentation and vendor communications.
• Coordinate trial documentation, vendor communications and study tracking to support global clinical operations teams
• Collaborate with Clinical Trial Managers, CRAs, regulatory teams and external partners to ensure timely study execution
• Track study milestones, manage essential documents and support reporting across clinical programs
• Assist with preparation and management of study materials including investigator meeting documentation and training materials
• Support audit and inspection readiness activities and ensure compliance with ICH-GCP and internal procedures

Skills

Clinical trial support

Regulatory process understanding

Organizational skills

Communication skills

Cross-functional collaboration

Organisational skills

Communication skills

Job description

Senior Clinical Research Associate | London, UK | 6-Month Contract (Full-time) HYBRID

Key responsibilities

• Support the day-to-day operational delivery of Phase I–III clinical trials across multiple complex indications
• Maintain and oversee Trial Master File (TMF) quality and completeness to ensure inspection readiness
• Assist with study start-up activities including site documentation collection, regulatory submissions and site activation support
• Coordinate trial documentation, vendor communications and study tracking to support global clinical operations teams
• Collaborate with Clinical Trial Managers, CRAs, regulatory teams and external partners to ensure timely study execution
• Track study milestones, manage essential documents and support reporting across clinical programs
• Assist with preparation and management of study materials including investigator meeting documentation and training materials
• Support audit and inspection readiness activities and ensure compliance with ICH-GCP and internal procedures

Candidate requirements

• Minimum 5 years’ experience as a Clinical Trial Associate or within a comparable clinical operations role
• Strong experience supporting Phase I–III clinical trials
• Experience working within biotechnology environments, ideally supporting innovative or complex therapeutic programs such as cell or gene therapy
• Exposure to multiple complex therapeutic areas and global clinical trial operations
• Strong understanding of clinical trial documentation, TMF management and regulatory processes
• Excellent organisational skills with the ability to manage multiple studies and priorities simultaneously
• Strong communication skills and ability to work effectively within cross-functional clinical teams

What is offered

• Opportunity to work within an innovative cell therapy biotech environment
• Exposure to cutting-edge clinical development programs