Hobson Prior are currently seeking a CTMA II 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 is an exciting contract role located in Uxbridge, London.
- Accountable to manage European Country components of Phase 2 or 3 trials as a member of the study team.
- Coordinates CROs or vendors as required and demonstrates an ability to work independently.
- Assists 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 organisation's SOPs and protocol procedures, and review of routine regulatory documents/files in compliance with protocol, regulatory requirements, SOPs, and Monitoring Plan, as required.
- May assist in review of protocols, informed consents, and case report forms, monitoring 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, CCF, Materials and Logistics, and Drug Safety and Public Health to ensure efficient management of study activities.
- Assists in preparation of safety, interim and final study reports, including resolving data discrepancies.
- Ability to identify solutions to study issues based on precedent
- Must be able to participate in departmental or interdepartmental strategic initiatives under general supervision as required.
- 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.
- Typically requires a BSc or BA in a relevant scientific discipline or RN qualification.
- Relevant clinical trial experience in the pharmaceutical or health care industry or equivalent.
- Must have a general understanding of functional issues and routine project goals from an organizational perspective.
- CRA experience preferred.
- Inflammation experience preferred but not essential.
- Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable.
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.
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