CLINICAL TRIAL SPECIALIST

Thornshaw Scientific, on behalf of our client, a Global Pharmaceutical Company now have a new vacancy for a Clinical Trial Specialist. Working with the Global Clinical Operations Director you will drive the clinical operational process management, quality assessment, SOP, process review and implementation.

Key Responsibilities:

To provide general administrative support to the Clinical Operations Department and assistance to Project Manager(s) and Project Director(s).
To assist the Clinical Operations teams in completion of all required tasks to meet departmental and project goals.
To support the Clinical Operations teams with ongoing conduct of studies.
To be familiar with ICH GCP, appropriate regulations, relevant SOP’s and internal tracking systems.
To be familiar with the roles of the Clinical Research Associates (CRA) including site visits, if appropriate.
To assist project teams with study specific documentation and guidelines as appropriate.
To set up, organize and maintain clinical study documentation (e.g. Main Study Files, CRFs, etc.) including preparation for internal/external audits, final reconciliation and archival.
To process Data Collection Forms i.e. log in, tracking, quality control as appropriate for the study.
To assist in quality control audits of clinical study documentation (e.g. Main Study Files, CRF Files, Monitoring Files, etc.).
To co-ordinate ordering/dispatch and tracking of trial materials (e.g. CRFs, diary cards, lab supplies, drug supplies) as appropriate.
To assist project teams with trial progress tracking by updating the Clinical Trial Management systems.
To assist in the tracking and distribution of safety reports.
To co-ordinate document translation, if required.
To attend project team meetings and generate meeting minutes.
To assist the Project Manager and project team with Investigator Meeting coordination, activities preparation and generate meeting minutes.
To assist in the production of slides, overheads, etc., as needed for project, departmental, sponsor and/or business development presentations.

Qualification / Experience:

3+ years of relevant experience, preferably from the Sponsor side
Life Science, research or health care related educational background
Good organizational skills, ability to manage multiple tasks and meticulous attention to detail.
Good written and verbal communication skills

For full job spec and information please send your CV to [email protected] or call Tina at +353 1 2784701 / 087 6811990. Thornshaw Scientific is a division of the CPL Group of companies. www.thornshaw.com

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Tina Dunne