Hobson Prior are currently seeking a Clinical Project Manager for a biotechnology company based in Hertfordshire, on a permanent basis. Our client is currently working within early phase and ideally would look for individuals with previous exposure to early phase studies. In this role you will work with the Director of Clinical Operations and team to guide the execution of the deliverables for the clinical studies whether interventional or observational.
- Monitoring of study deliverables and support vendor relationships.
- Carry out protocol-related site management activities.
- Involvement in study planning and set-up activities including vendor management, project management, and coordination of study and implementation plans.
- Contribute to the design, content, and preparation of clinical protocols, amendments, consent forms, study guides, monitoring plans, CRFs, and subject information sheets as well as quality system maintenance for clinical programs.
- Assist in the identification of clinical trial investigators as required.
- Coordinate and take direct responsibility for activities associated with site start-up and management including review site-modified informed consent templates. May be required to be involved in the tracking of the budget and contract process.
- Monitor/Co-Monitor study sites.
- Contribute to or coordinate preparation and conduct of monitors workshops and investigator meetings.
- Provide input for screening and enrolment progress.
- Coordinate study-level investigational product arrangements and accountability and reconciliation
- Take part in and support study teams and other cross-functional teams as necessary.
- Deliver clinical site/CRO, vendor support by answering protocol-specific questions.
- Resolve patient eligibility questions and protocol deviations in cooperation with the Director of Clinical Operations, the Head of Clinical Research and the CRO.
- Co-operate with the CRO, the central lab and the Analytical team to coordinate shipment and analysis of clinical biological samples.
- Guide and monitor CRO and third-party vendor activities, including relationships and training, and the development of vendor specifications and scopes of work.
- Use relevant reports and identify progress of CRF data collection and query resolution.
- Monitor progress of studies, identify study-related trends/issues and work with the clinical Director of Clinical Operations and CRO to implement corrective actions when necessary.
- Assist in preparation and quality control of Clinical trial applications, clinical study reports, and regulatory submissions.
- Ability to write and present clearly using scientific and clinical terminology.
- Capable of dealing with time demands, incomplete information and unexpected events.
- Good organisational and planning skills.
- Capable of working effectively in a team/matrix environment.
- Demonstrate initiative and creative thinking for problem solving.
- Life Sciences Degree - MSc or PhD.
- Previous biopharmaceutical clinical operations experience.
- Broad experience in life sciences or medically related field, including general knowledge of biopharmaceutical clinical research.
- Understanding of drug development process.
- Knowledge in clinical trial technologies (EDC, IVRS, WVRS, Vendor dashboards).
- Experience in interactions with vendors, such as CROs and contract labs.
- Involvement with administration of site budgets and grants with supervision.
- Experience with development of prospective site-selection criteria.
- Previous experience of reviewing adequacy of site-proposed ICs for compliance with relevant regulations.
- In-depth knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements.
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.