Hobson Prior are looking for a Clinical Project Manager for an exciting opportunity to join an expanding gene therapy organisation expanding in NYC. You will be responsible to support the execution of gene therapy studies per development plan, from initiation through to closeout.
- Prepare and submit HRA application package for clinical trials approvals in the UK, and support approvals application process in the US.
- Uphold knowledge of therapeutic area, current GCP and Statutory Instruments.
- Support project team members to be compliant with current ethical and regulatory guidelines and requirements.
- Report on team performance against contract and project expectations.
- Co-operate with the study teams to ensure clinical milestones are achieved and to ensure issues and obstacles are managed accordingly.
- Develop study management plan, project team assignments and provide oversight of databases.
- Alleviate clinical risk by problem solving and contingency plan development.
- 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 throughout the team.
- Conduct co-monitoring visits.
- Recognise and contribute to compilation and delivery of study associated documentation (protocols, IB, ICF, etc).
- Review trial data and procedures ensuring good quality data.
- Establish and maintain good communication and relations with stakeholders in the clinical programmes including investigators, CROs, and regulatory consultants.
- Deliver input for development of new proposals.
- Participate in the development of the clinical quality management system through the development and review of Standard Operating Procedures and supporting documents.
- Educated to Degree level (or equivalent) in a Biological Science discipline.
- Minimum of 5+ years of clinical trial management experience to include trials of an advanced medicinal product.
- 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.