Hobson Prior are currently seeking a Senior Clinical Project Manager to join an advanced therapy company on a permanent basis. This role will entail the planning, implementation and monitoring of the progress of clinical trials and to be responsible for overall day-day operational management.
- Accountable for implementing, controlling and evaluating assigned clinical projects.
- Responsible for the successful delivery of clinical trials conducted in the UK and EU, including oversight of third-party vendors.
- In cooperation with the Head of Clinical Development, Project Management and Sponsor representatives you will be responsible for the development of clear and measurable project management plans.
- Design and implementation of site selection, monitoring and recruitment plans.
- Preparing and reviewing protocols, CRFs and informed consent documents as well as other documents required to run clinical trials.
- Accountable for TMF management and to ensure studies are inspection ready and regulatory compliant.
- Support a clinical project team, external collaborators and the organisations clients.
- In charge of the cross-functional team's compliance with the project Standard Operating Procedures, Good Clinical Practice, International Conference on Harmonization guidelines and other regulations.
- Develop and supervise systems to track projects including all study, investigator and ethical review board information, patient recruitment activity and financial management.
- Navigate and communicate within the NHS structure for trial approvals, contract negotiations and at sites.
- Partake in the development and review of departmental Standard Operating Procedures, guidelines, and intra-departmental procedures and other continuous process improvements programs, as assigned.
- Capable to efficiently find solutions to problems and suggest resolutions to the Head of Clinical Development.
- Strong interpersonal, communication skills (both verbal and written) with flexibility towards work assignments, new learning and travel.
- Capable to work quickly and accurately, with limited supervision and ability to use own initiative.
- Upkeeps professional knowledge of expertise and best practice.
- A minimum of 4 years’ experience within clinical project management.
- 2 years of EU multi-national trials experience, or relevant experience.
- A minimum of 7 years clinical research background, including clinical monitoring with medical and/or scientific experience would be preferred.
- Understand the UK regulatory environment and NHS operational requirements.
- Understand the detail of GCP regulation.
- Prior experience in managing a diverse and complex workload.
- Up to 20% travel will be required within the UK with potential for some EU travel.
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.