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 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
- 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.
Job Requirements: In addition to the core duties outlined, the following qualifications are required for the Site Start Up EUCTR Level I
- 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.
