Clinical Project Manager
- Experience Level
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 Project Manager to contribute to the execution of gene therapy projects per development plan, from initiation through to closeout.
- Support project team members to be compliant with current ethical and regulatory guidelines and requirements.
- Support budget negotiation and trial agreements with sites.
- Oversee program budget and provide input.
- Develop project management plan and be responsible for cross functional project meetings
- Communicate with data management team and external vendors to ensure data is reported accurately and in a timely manner for the responsible program.
- Accountable for outsourced vendor management oversight and invoicing.
- Responsible for the communication of timelines across the team members to ensure efficient production, scheduling and delivery of project.
- Accountable for oversight of TMF review and maintenance and for clinical operations inspection readiness.
- Collaborate internally and externally to ensure clinical milestones are achieved and to ensure issues and obstacles are managed accordingly.
- Mitigate clinical risk by problem solving and contingency plan development.
- Oversee site and team communications and compliance with regulations and SOPs.
- Oversee and support quality assurance.
- 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.
- 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.
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.