Site Start Up EUCTR I

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Job Title: Site Start Up EUCTR I

• Responsible for planning and submitting the simple EUCTR submissions i.e. Phase I initial submissions, Mono national initial submissions, substantial and non-substantial modification submission etc.

CORE JOB RESPONSIBILITIES:

· Collaborate with Clinical Trial Management functional representatives to determine key study milestones and country allocation strategies.

· Engage with Regulatory Affairs functional representatives to plan the part-II Clinical Trial Application (CTA) for EU countries.

· Identify the list of Member State/countries participating in any one clinical trial and capture the information within the CTIS database.

· Identify the Institutions and Primary Investigators for each Member State/Country where the clinical trial will be conducted and capture relevant contact information within the CTIS da...