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 Programme Manager to be responsible for supporting the planning and execution of gene therapy programmes per development plan, from initiation through to closeout.
- Participate in the clinical and business project planning of the companies Gene therapy programmes.
- Support the Clinical Research & Development projects, providing knowledge of all aspects of clinical development including supporting the day to day management of the clinical operations department.
- Co-operate with stakeholders to ensure development milestones are achieved, and issues and obstacles are managed accordingly.
- Support oversight of vendor management.
- Guide the communication of timelines across the team members to ensure efficient production, scheduling and delivery of projects.
- Highlight potential risks, and actual issues with quality, budget or timelines to the senior leadership team.
- Deliver oversight of project management plan development and assignments.
- Provide oversight of Quality Management components of studies. Escalate potential risks, issues, findings and corrective actions as appropriate.
- Support contract negotiations in relation to study matters.
- Facilitate continual improvements to internal processes to improve efficiency.
- Participate in internal and external audits as planned and report non-conformances and recommendations for improvement.
- Contribute to the development of the clinical quality management system through the development and review of Standard Operating Procedures and supporting documents.
- Support the oversight of the data transfer process at the vendor level.
- Take part in the development of key study documents such as clinical protocols, Investigator Brochures and Development Safety Update Reports.
- Ability to work unsupervised.
- Strong interpersonal skills to influence, communicate and manage change.
- Educated to Degree level (or equivalent) in a Biological Science discipline.
- Prior experience of running projects in the gene therapy or advanced therapies arena.
- Significant experience of working in a translational clinical research environment.
- Proven strong project management experience.
- Vast experience of business operations including Quality Management Systems, awareness of Expenditure and Processing of Requisitions.
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.