Job expirat
Study Start-up Specialist
Department: Clinical - Submissions and Investigator Services
Location: Romania
Base: Office Based
Employment Type: Permanent
Role Responsibility:
Site activation is currently one of the most challenging aspects within the project lifecycle. Due to the fast nature of the business the company works within, we’re looking to develop our team to reach for new frontiers of performance and quality. 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 immediate consideration please apply online now via this link - http://clinicalresearchjobs.eu/Study-Start-Up-Specialist-Study-Start-Up-Specialist-Jobs-Romania
or contact:
Eamonn O’Raghallaigh MSc on +353 16854848 or email applications@lifescience.ie
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