Job Title: Site Start Up EUCTR I
- Responsible for planning and submitting the straightforward 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 database.
- Collect 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.




- Liase with Clinical Transparency regarding any redactions required for relevant documents identified for CTA submissions.
- Monitor and report on the progress of Part II activities to ensure alignment with overall trial timelines and objectives.
- Ensure part-II CTA comply with national regulatory requirements in each member state where the trial is conducted
- Collect required documents for IVDR (In Vitro Diagnostic Regulation) ethics submission and ensure all collected documents comply with the IVDR country requirements.
- Ensure that all trial-related documents are archived in compliance with regulatory requirements and company policies.
- Maintain and manage the list of participating Member States/countries, Institutions and Primary Investigator over the life cycle of the study to ensure alignment and synchronization.

Job Requirements: In addition to the core duties outlined, the following qualifications are r

📌 Site Start Up Euctr I (Delhi)
🏢 Parexel
📍 Delhi