Hobson Prior are currently seeking a Clinical Project Manager for a biotechnology company based in Hertfordshire. Our client is currently working within early phase and ideally would look for individuals with previous exposure to early phase studies. This role will entail working with the Director of Clinical Operations team to guide the execution of the deliverables for the clinical studies whether interventional or observational.
- Participate in study planning and set-up activities including vendor management, project management, and coordination of study and implementation plans.
- Monitor study deliverables
- 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.
- Carrying out protocol-related site management activities.
- Guide vendor relationships
- Support in the identification of clinical trial investigators.
- Take direct responsibility for activities associated with site start-up and management including review site-modified informed consent templates.
- Monitor/Co-Monitor study sites.
- Co-ordinate preparation and conduct of monitors workshops and investigator meetings.
- Work closely with the Director of Clinical Operations and assigned CRO to develop recruitment strategies.
- Provide input for screening and enrolment progress.
- Coordinate study-level investigational product arrangements and accountability and reconciliation.
- Partake in and support study teams and other cross-functional teams as necessary.
- Work with the Director of Clinical Operations, the Head of Clinical Research and the CRO to resolve patient eligibility questions and protocol deviations.
- Work with the CRO, the central lab and the Analytical team to coordinate shipment and analysis of clinical biological samples.
- Recognise any study-related issues and work with the Clinical Director of Clinical Operations and CRO to take necessary actions.
- Guide preparation and quality control of Clinical trial applications, clinical study reports, and regulatory submissions.
- Capability to write and present clearly using scientific and clinical terminology.
- Able to understand technical, scientific and medical information.
- Be able to deal with time demands, incomplete information and unexpected events.
- Able to show initiative and creative thinking for problem solving.
- Experience working effectively in a team environment.
- Good organisational and planning skills
- Advanced computer skills
- 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 focussed 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.