CTMA II - Virology
Hobson Prior are currently seeking a CTMA II - Virology for a research-based biopharmaceutical company. Our client is very patient-focused, whose scientific research has benefitted hundreds of thousands of people by ensuring medications are available to those who could otherwise not afford them. This position will be accountable for assisting global trial managers on Phase Ib-III clinical studies, with a strong emphasis on the EMEA region.
- You will provide administrative assistance in site selection, study implementation and ongoing coordination of study sites, either directly or via CROs.
- Assist global trial managers with set-up of central labs and study vendors as required, including liaising with study management CRO to ensure site training and timely initiation.
- Performs accompanied visits (PSSVs, SIVs, RMVs) with CRO CRAs to ensure correct study procedures according to the organisations SOPS and protocol procedures.
- Review of routine regulatory documents/files in compliance with protocol, regulatory requirements, SOPs, and Monitoring Plan, as required.
- Under supervision may assist in review of protocols, informed consents, and case report forms, monitoring plans, study plans, abstracts, presentations, manuscripts and clinical study reports.
- Review of trip reports generated by CRO CRAs.
- Communicates and collaborates with other functional groups including but not limited to Clinical Research, Regulatory Affairs, Development Business Operations, Clinical Supply Management and Pharmacovigilance to ensure efficient management of study activities.
- Assists with the preparation and organization of international investigator meetings.
- Assists in preparation of safety, interim and final study reports, including resolving data discrepancies.
- Completes administrative duties in a timely manner as assigned.
- Educated to degree level or equivalent within a relevant scientific discipline
- Minimum 3 years relevant clinical trial experience in the pharmaceutical or health care industry or equivalent.
- CRA experience is preferred.
- Excellent verbal, written, interpersonal and presentation skills are required.
- Must be familiar with routine medical/scientific terminology.
- Must be familiar with Word, PowerPoint, and Excel.
- Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable.
- Must be able to participate in departmental or interdepartmental strategic initiative under general supervision.
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.
£250 - £300 per day
Hobson Prior are looking for a Clinical Program Coordinator to join a leading biopharmaceutical company who purely concentrate on neurology and immunology.
£440 - £460 per day
Hobson Prior are currently seeking a Clinical Trials Manager (Virology) for a research-based biopharmaceutical company. Our client is very patient-focused