Hobson Prior have an exciting contract position to join a Biotech organisation. Our client is looking for a Senior CTMA to worked part home based and part office.

Please note that to be considered for this role you must have the right to work in this location.

Job Responsibilities:

• You will complete accompanied visits with CRO CRAs to ensure correct study procedures according to the organisations 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, study plans, abstracts, presentations, manuscripts and clinical study reports. May assist in compilation of investigator brochures under close supervision.
• Evaluation of trip reports generated by CRO CRAs.
• Must meet all requirements for Clinical Trial Management Associate position and have demonstrated proficiency in all relevant areas.
• You will deliver 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.
• Communicates and partners with other functional groups including but not limited to Clinical Research, Regulatory Affairs, Development Business Operations (DBO), Clinical Supply Management (CSM) and Pharmacovigilance to ensure efficient management of study activities.
• Supports with the preparation and organization of international investigator meetings
• Supports in preparation of safety, interim and final study reports, including resolving data discrepancies.
• To performs administrative duties in a timely manner as assigned.

Requirements:

• Educated to degree level or equivalent within a relevant scientific discipline.
• Relevant clinical trial experience in the pharmaceutical or health care industry or equivalent.
• CRA experience 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.

Apply now:

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.