Hobson Prior are looking for a Senior Clinical Trial Management Associate to join a research-based biopharmaceutical company on a contract basis. 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.
- Delivers administrative assistance in site selection, study implementation and ongoing coordination of study sites, either directly or via CROs.
- Support global and European 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 with CRO CRAs to ensure correct study procedures according to company SOPs and protocol procedures, and 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, abstracts, presentations, manuscripts and clinical study reports.
- Review of trip reports generated by CRO CRAs.
- Co-operates with other functional groups including but not limited to Clinical Research, Regulatory Affairs, CCF, Materials and Logistics, and Pharmacoviligence and Epidemiology to ensure efficient management of study activities.
- Assists in the Management of the CRO’s and vendors as required.
- Supports 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 communication.
- Presentation skills.
- Typically requires a BSc or BA in a relevant scientific discipline or RN qualification.
- Minimum of 3 years relevant clinical trial experience in the pharmaceutical or health care industry or equivalent.
- CRA experience preferred and/or experience in a similar role.
- Understand routine medical/scientific terminology.
- Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCP governing the conduct of clinical trials is desirable.
- Travel is required up to 20-30%, depending on the stage and needs of the clinical trial.
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.