Site Start Up EUCTR

Job Title:
Site Start Up EUCTR I

• 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 red actions 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.
• Triage any questions that surface (Requests For Information) as a result of capturing and/or reporting on REGN clinical trial applications and work with relevant stakeholders to have RFI responses generated.
• 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.
• 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.
• 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.

• Interpersonal & leadership skills.
• Ability to understand and implement the operational strategic direction and guidance for respective clinical studies.
• A data driven approach to planning, executing, and problem solving.
• Effective communication skills via verbal, written and presentation abilities.
• Proactive and self‑disciplined, ability to meet deadlines, effective use of time, and prioritization.
• Ability to build productive study teams collaborations.
• Vendor management experience.
• Basic proficiency in trial management systems (CTMS, TMF) and MS applications including (but not limited to) Project, PowerPoint, Word, Excel.
• Experience in the clinical drug development process, including study start‑up.
• Knowledge of ICH/GCP, EUCTR and IVDR regulatory guidelines.
• Basic project management skills, cross‑functional team interaction and organizational skills.
• May require up to 25% travel.
• Bachelor’s degree and 1-2 years of relevant experience.