This Clinical Trial Administrator job is with one of the most renowned global pharmaceutical, medical device and consumer health organisations located in Leeds, UK. The organisation is a top 10 pharma company and employs over 100,000 professionals worldwide. This individual will provide support to the clinical study staff within the Clinical R&D COE, as well as fostering strong, productive relationships with colleagues within the Clinical R&D COE organization.
- Under general supervision, accountable for the timely tracking of study essential documents and ensuring completeness of the Trial Master File for assigned clinical studies according to appropriate regulations, departmental guidelines, and work instructions.
- Creation/distribution of regulatory binders & the wet-ink signed documents binder
- Assist study staff and investigators to quickly and effectively resolve issues relating to Study Files (Trial Master File and Investigator Site File). Respond to problems and assists in implementing corrective and preventive actions.
- Assist in providing internal communication of important clinical data and events.
- Support ongoing use of CTMS by maintaining and tracking relevant activities.
- Provide safety documentation to other functional groups in support of safety committee meetings as requested (supporting role).
- Other Administrative Tasks
- May be asked to provide support for study supplies creation, ordering and distribution to the sites e.g. print protocols, burn DVDs
- May be asked to assist with Device tracking and ordering if required and if applicable.
- Assistance with logistics for Investigator meetings/expert panel meetings
- Assistance with distribution of newsletter (create mailing list from CTMS and routing for internal approval)
- Participates in process improvement activities related to CTMS/v-TMF within the department.
Skills and Requirements:
- Minimum of a Bachelor’s Degree is required.
- Previous clinical research experience a plus.
- Requires previous administrative support experience or equivalent for at least 1 year.
- Clinical/medical background a plus.
- Requires experience and knowledge working with computer systems (Microsoft office - Excel, Word and Power Point).
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 call Matthew Pike on +44 207 4400 639 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.