Clinical Trial Manager

Want to work for a fast-based biotech working in cutting edge gene therapy? We’re looking for a Clinical Trial Manager with minimum1 year experience with a willingness to learn and join our clinical operations team! If you’re interested, we’d love to hear from you.

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

Responsibilities

• Manage 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 vendors relationship and ensure deliverables meet quality standards

• Contribute to the development of clinical strategy, protocols, and operational plans.

• 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.

• Coordinate and manage with external partners (e.g. CROs, labs, sites) including contract and budget negotiations.

• Assist in development of monitoring visit plan and report templates, including quality control check of completed visit reports (site qualification, initiation and close-out).

• Support regulatory submissions, audits, and inspections.

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

Qualifications and Experience

• Experience (1-3 years) in clinical project management within a pharma, CRO or biotech setting essential

• Life sciences degree (or equivalent)

• Strong ability to communicate clearly and in a concise manner, both verbally and in writing

• Ophthalmology experience desired but not essential

• Experience managing CROs, vendors, and study sites

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

• Prior exposure to and understanding of international clinical trial set up

• Understanding of different phases of the clinical trial, ideally from study initiation to closeout

• Strong ability to communicate clearly and in a concise manner, both verbally and in writing

• Excellent problem-solving skills

• Creative solution finder with ability to think ahead

• Good attention to detail

• Demonstrates a lot of initiative and can-do attitude

• Does not shy away from challenges