Clinical Trial Manager
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Hobson Prior is currently working with a gene therapy organisation who are determined to develop possible curative treatments for patients who are living with serious illnesses. This innovative company is seeking a Clinical Trial Manager to contribute to the execution of gene therapy studies per development plan, from initiation through to closeout.
- You will prepare and submit HRA application package for clinical trial 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.
- Accountable 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.
- Ensure regulatory compliance in terms of MHRA, FDA and EU framework.
- Understand and adhere to the principles of ICH GCP and regulatory requirements in both the EU and US.
- Educated to Degree level (or equivalent) in a Biological Science discipline.
- A minimum of 5+ years of clinical trial management experience to include trials of an advanced medicinal product.
- A minimum of 2+ years of clinical trial management experience in a commercial setting.
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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