CLINICAL TRIAL SPECIALIST
Thornshaw Scientific, on behalf of our client, a Global Pharmaceutical Company, now has 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:
* Provide general administrative support to the Clinical Operations Department and assistance to Project Manager(s) and Project Director(s).
* Assist the Clinical Operations teams in completion of all required tasks to meet departmental and project goals.
* Support the Clinical Operations teams with ongoing conduct of studies.
* Be familiar with ICH GCP, appropriate regulations, relevant SOPs, and internal tracking systems.
* Be familiar with the roles of the Clinical Research Associates (CRA), including site visits, if appropriate.
* Assist project teams with study-specific documentation and guidelines as appropriate.
* 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.
* Process Data Collection Forms, i.e., log in, tracking, quality control as appropriate for the study.
* Assist in quality control audits of clinical study documentation (e.g., Main Study Files, CRF Files, Monitoring Files, etc.).
* Coordinate ordering/dispatch and tracking of trial materials (e.g., CRFs, diary cards, lab supplies, drug supplies) as appropriate.
* Assist project teams with trial progress tracking by updating the Clinical Trial Management systems.
* Assist in the tracking and distribution of safety reports.
* Coordinate document translation, if required.
* Attend project team meetings and generate meeting minutes.
* Assist the Project Manager and project team with Investigator Meeting coordination, activities preparation, and generate meeting minutes.
* 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 healthcare-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 tdunne@thornshaw.com 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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