Clinical Trial Manager
A leading Clinical Stage gene therapy company focused are currently hiring a Clinical Trial Manager. Based in London, this incredible organisation is offering a bright and dynamic individual an opportunity to bring their expertise to an established company while changing the face of medicine.
- Prepare and submit applications for clinical trail approvals in the UK, and support approvals in the UK and support approval application process in the US
- Negotiate budgets and trial agreements with sites.
- Approve invoices within scope of agreed budget for assigned studies
- Accountable for site management and communication with sites
- Accountable for site initiation activities including feasibility and the regulatory site activation process
- Liaise with data management team and external vendors to ensure data is reported accurately and in a timely manner for the responsible studies
- Responsible for outsourced vendor management oversight and invoicing for responsible studies.
- Accountable for TMF review and maintenance of clinical operations inspection readiness for studies
- Collaborate internally to ensure clinical milestones are achieved and to ensure issues and obstacles are managed accordingly
- Regularly review site and team communications, Monitoring Visit Reports and quality assurance audit findings to assess quality issues within the project.
- Implement corrective action plans and ensure appropriate escalation through the team
- Conduct co-monitoring visits
- Contribute to compilation and delivery study associated documentation
- Ensure investigators and research staff training needs are met
- Establish and maintain good communication and relations with stakeholders in the clinical studies including investigators, CROs and regulatory consultants
- 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
- Accountable for set up and maintenance of Trial master file.
Skills and Requirements
- Degree (or equivalent) in a Biological Science discipline
- 5+ Years of clinical trial management experience to include trials of an advanced medicinal product
- Ability to manage projects, multitask, and execute plans
- Good interpersonal skills, including communication, presentation, persuasion and influence
- God organisational skills, including efficiency, punctuality and collaboration in a team environment
- Proficiency using computer skills, such as MS Office
Please click on the Apply button. Kindly include a short note outlining why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Matthew Pike at 02074400639 or upload your CV on our website - www.proclinical.com
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.