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Hobson Prior are currently seeking a CTMA for an exciting position at 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.
- To manage European Country components of Phase 2 or 3 trials as a member of the study team.
- You will provide assistance in site selection, study implementation and ongoing coordination of study sites, either directly or via CROs.
- Coordinates CROs or vendors as required and demonstrates an ability to work independently.
- 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.
- Completes 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.
- Review of trip reports generated by CRO CRAs.
- May assist in review of protocols, informed consents, and case report forms, monitoring plans, abstracts, presentations, manuscripts and clinical study reports.
- 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.
- May be asked to assist in the training of Clinical Trial Management Associates and Clinical Project Assistants.
- May coordinate the preparation and organization of international investigator meetings.
- Assists in preparation of safety, interim and final study reports, including resolving data discrepancies.
- Excellent verbal, written, interpersonal and presentation skills are required.
- An ability to identify solutions to study issues based on precedent.
- 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.
- Must be familiar with routine medical/scientific terminology.
- Must be familiar with Word, PowerPoint, and Excel.
- CRA experience would be 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.
- Must be able to participate in departmental or interdepartmental strategic initiatives under general supervision as required.
- Travel is required up to 10- 20%.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" 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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