Clinical Trial Coordinator / Associate Clinical Study Manager
A leading biotechnology company is currently recruiting for a Clinical Trial Coordinator / Associate Clinical Study Manager position. The organisation specialises in the rare disease field and is seeking a driven individual to join their team based in Hertfordshire. This is an exciting opportunity to bring expertise and skills to an established, flexible working and in-demand company.
- Providing administrative assistance in site selection, study implementation and ongoing coordination of study sites, either directly or via CROs.
- 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.
- Performing accompanied visits (PSSVs, SIVs, RMVs) with CRO CRAs to ensure correct study procedures according to Gilead 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 reviewing 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.
- Reviewing of trip reports generated by CRO CRA.
- Communicating and collaborating with other functional groups including but not limited to Clinical Research, Regulatory Affairs, CCF, Materials and Logistics (M&L), and Drug Safety and Public Health (DSPH) to ensure efficient management of study activities.
- Assisting with the preparation and organisation of international investigator meetings.
- Assisting in preparation of safety, interim and final study reports, including resolving data discrepancies.
- Performing administrative duties in a timely manner as assigned.
Skills and Requirements:
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency in computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Matthew Pike on 0207 440 0639 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.