Associate Clinical Trial Manager

Want to work for a fast-based biotech working in cutting edge gene therapy? We’re looking for an Associate Clinical Trial Manager with a minimum of 1 year's experience in clinical project management within a pharma, CRO or biotech setting, and a Life sciences degree (or equivalent). The role will report to the Senior Clinical Trial Manager. If you’re interested in joining our Clinical Operations team, we’d love to hear from you. 

The Associate Clinical Trial Manager will play an important role in supporting the Clinical Operations team in the management of interventional and observational clinical studies in ophthalmology and subretinal gene therapy. The Associate Clinical Trial Manager will play a pivotal role in the Clinical Operations team.

The role is full-time hybrid working on two consecutive days on the week, in the London office based in White City.

Responsibilities

• Support cross-functional teams and work closely with CROs, investigators, and internal stakeholders to ensure our clinical studies are delivered on time, within budget, and to the highest quality standards

• Support the operational execution of observational and interventional clinical trials with timeline adherence, trial budgets and project quality deliverables

• Manage service provider relationships and ensure deliverables meet quality standards. 

• Assist with the creation and review of informed consent documents and other patient-facing materials

• Assist in study start-up activities including site selection and review of essential regulatory documentation

• Assist in development of monitoring visit plan and report templates, including monitoring oversight of completed visit reports (from site qualification to close-out)

• Support regulatory submissions, audits, and inspections

• Ensure compliance with ICH-GCP, regulatory requirements, and internal SOPs

Requirements

• Experience as a Clinical Research Associate (CRA) highly desirable

• Ophthalmology experience desired but not essential

• Excellent written and verbal communication and organisational skills

• Experience managing CROs, vendors, and study sites

• Strong knowledge of ICH-GCP and global clinical trial regulations

• Strong interpersonal and team working skills within a fast-paced, growing, hands-on biotech environment

• Able to work independently, is self-motivated and comfortable using initiative where required

Salary: up to £52 000 base depending on experience