Clinical Trial Manager
£50,000 – £55,000
Permanent
Are you an experienced Clinical Trial Manager looking for your next opportunity in London?
We are working alongside our client, a clinical-stage gene therapy company that focuses on the development of treatments for serious diseases such as diseases of the eye, salivary gland, and central nervous system diseases. They are looking for a Clinical Trial Manager to contribute to the execution of gene therapy studies and ensure that all project deliverables are completed in accordance with SOP’s.
You will oversee a team that is made up of expertise in gene therapy development, who are proudly developing proprietary technology with the idea to enable innovative gene therapy treatments with expressions that can be turned on and off with an easily administered small molecule.
Key Duties
- Oversees all operational clinical research activities
- Oversees execution of studies according to ICH/GCP guidelines
- Prepare and submit HRA application package for clinical trial approvals in the UK, and support approval application process in the US
- Approve invoices within scope of agreed budget for assigned studies
- Accountable for site management and communication with sites
- Responsible for outsourced vendor management oversight and invoicing for responsible studies
- Monitors and assesses vendor performance against contractual operational deliverables
- Regularly review site and team communications, Monitoring Visit Reports and quality assurance audit findings to assess quality issues within the project
- Contribute to compilation and delivery of study associated documentation (protocols, IB, ICF, etc)
- Oversees the development of study manuals and monitoring manuals
- Contribute to the development of the clinical quality management system through the development and review of Standard Operating Procedures and supporting documents.
- Contribute to audits and inspections as requested
- Makes recommendations for improving resources (tools, systems, vendors etc) needed by the team
- Responsible for ensuring that any GMP documentation e.g. (but not limited to) Issues, CAPAs, Change Controls, BMRs & audit/inspection actions, within own area of responsibility, is closed timely and in a RFT state
Experience
- Educated to Degree level (or equivalent) in a Biological Science discipline
- At least two years of clinical trial management experience
- At least four years being a Clinical Research Associate to a Senior level
If you have previous experience working as a Clinical Trials Manager and want to be a part of an exciting, friendly, and hardworking company, apply today!
