CTIS Administrator

Responsible for planning and delivery of European Union Clinical Trials Directive / Regulation (EUCTD / R) reporting according to the Part II requirements outlined by the European Medicines Agency (EMA) via the Clinical Trial Information System (CTIS). Coordination with Regulatory Affairs, Clinical Trial Management and Clinical Transparency will be core to the role.

Key Accountabilities

Operations Management :

• Engage with Regulatory Affairs functional representatives to plan the Clinical Trial Application (CTA) for any one up and coming clinical trial that involves EU countries
• Engage with Clinical Trial Management functional representatives to determine key study milestones and country allocation strategies
• Coordinate with Clinical Transparency regarding any redactions required for relevant documents identified for CTA submissions
• Identify the list of Member State / countries participating in any one clinical trial and capture the information within the CTIS database
• Identify the key study level and Member State / country level milestones that represent Study Start, Study Completion, Enrollment Start, Enrollment Completion and any potential hold / restart / cancel dates that may apply to the study and capture the relevant dates 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 database
• Locate the documents that are deemed applicable at the Member State / country and / or site level for the purposes of Clinical Trial Application (CTA) submissions and upload them into the CTIS database
• Maintain the list of participating Member States / countries, Institutions and Primary Investigator over the life cycle of the study to ensure alignment and synchronization.
• Triage any questions that surface (RFIs, Requests For Information) as a result of capturing and / or reporting on REGN clinical trial applications
• Engage and oversee any vendor engaged to help collect, enter and / or maintain relevant information regarding Clinical Trial Applications (CTA) via the EMA CTIS database

Document Management

Compliance With Parexel Standards

Skills

Knowledge And Experience

Minimum 1-3 years of relevant / clinical essential document review experience

Education

Skills Required

ich gcp