Job Ref: 213987774

Date: 2021-06-16 09:39:05

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An excellent opportunity has arisen for a Clinical Trial Administrator to join a Pharmaceutical client based in Leeds.  This individual will provide support to the clinical study staff within the Medical Device Group, as well as fostering strong, productive relationships with colleagues within the Medical Device Group organization.  You will also be responsible for processing, tracking, and filing of study documents, and management of the Trial Master File within the clinical projects. In addition, administratively support clinical study staff as required.

– Clinical study administrative tasks 70%
– Other Administrative Activities 30%

Key Job Activities:

Clinical Administration Tasks – (includes CTMS build and tracking, v-TMF build & upload)
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.
Education:

Minimum of a Bachelor’s Degree is required.
Experience:

Previous clinical research experience a plus.
Requires previous administrative support experience or equivalent for at least 1 year.
Clinical/medical background a plus.
Knowledge:

Requires experience and knowledge working with computer systems (Microsoft office – Excel, Word and Power Point).
Additional Requirements:

Demonstrated competencies in the following areas are required
For further details, please contact Tim Barratt on (phone number removed) or email a copy of your CV to (url removed)

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