Hobson Prior is currently recruiting for a Senior CTMA to be based in Uxbridge on a contract basis. This is an exciting opportunity to join the Clinical Operations team at a thriving research-based pharmaceutical company.
- Delivers administrative assistance in site selection, study implementation and ongoing coordination of study sites, either directly or via CROs.
- You will perform accompanied visits with CRO CRAs to ensure correct study procedures according to the organisation’s SOPs and protocol procedures.
- Responsible for assisting 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.
- Review of routine regulatory documents/files in compliance with protocol, regulatory requirements, SOPs, and Monitoring Plan, as required.
- Accountable to communicate and collaborate 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.
- Review of trip reports generated by CRO CRAs.
- You may assist in review of protocols, informed consents, and case report forms, monitoring plans, abstracts, presentations, manuscripts and clinical study reports. May assist in compilation of investigator brochures under close supervision.
- You will support the management of the CRO’s, and vendors as required.
- 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.
- Ability to participate in departmental or interdepartmental strategic initiatives under general supervision as required.
- Can prioritise multiple tasks, plan proactively and accomplish goals using well defined instructions and procedures.
- Excellent verbal, written, interpersonal and presentation skills are required.
- Typically requires a BSc or BA in a relevant scientific discipline or RN qualification.
- A minimum 3 years relevant clinical trial experience in the pharmaceutical or health care industry or equivalent.
- CRA experience would be preferred.
- HIV experience is preferred but not essential.
- 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.
- Travel is required up to 20-30%.
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.