Our client is currently looking to recruit a Study Authorisation Associate for Dublin.

Role Responsibility:
You will be responsible for the preparation and approval of country related submission packages within specific timelines and quality standards. Collection of site level critical documents for Investigational Product (IP) release and site activation. Review and approving site level critical documents for Investigational Product release and site activation. Negotiating site level contracts to ensure sites are activated within the agreed timelines.

Additional Responsibilities:
•Working proactively as part of a project team you will coordinate all necessary activities required to gain Regulatory & Ethics Committee approval for clinical studies.
•You will be required to collate and prepare all documentation and dossiers for regional study approval in accordance with the relevant local legislations.
•Regular contact with the designated personnel from Regulatory Authorities & Ethics Committees must be maintained in order to monitor the submission progress in accordance with study start up deadlines.

Experience and Qualification
·Preferably with a degree in Life Sciences, you will have previous submissions/dossier experience within clinical studies for either a CRO or Pharma company. Develop, finalize and review Master and Country Specific Subject Information Sheets/Informed Consent Forms (SIS/ICFs)
·Prepare, finalize and review Master and Country Specific EU Clinical Trial Application Forms and corresponding data files (xml file)
·Review and translate Drug Labels and advise Sponsor on knowledge content for development of Drug Labels

For further information please call Linda at 01 2784671 or email your CV in the strictest confidence to ldunne@thornshaw.com . Log on to www.thornshaw.com for more jobs.

Study authorisation associate, clinical research, clinical trials