Start-Up Associate II
Pubblicato il 28-10-2026 - Allucent in Varese
Overview
Join Allucent as a Start-Up Associate II to lead local site start-up activities for clinical trials. You will coordinate regulatory and ethics submissions and serve as the primary point of contact with authorities, investigators, and sites through the initial study phase. You will manage documentation, timelines, and country-specific requirements to support timely Site Initiation Visits. This role partners with global teams to maintain compliant essential documents and contracts, enabling smooth site activation and trial progress. You will work in a dynamic, cross-functional environment focused on efficient start-up and high-quality submissions.
Retribuzione / Benefits
- Comprehensive benefits package per location
- Flexible Working hours
- Buddy Program
- Internal growth opportunities
- Employee referral program
- Spot Premio Award Program
Responsabilità
- Track start-up activities and milestones in CTMS or other tracking tools
- Ensure planned dates are current in CTMS for assigned activities
- File documents in the (e)TMF and assist others with filing
- Assist in preparation and submission of local regulatory documentation
- Provide documents in compliance with local regulations
- Support review of technical, pre-clinical and clinical reports for submissions
- Prepare and compile responses to regulatory agency questions
- Monitor regulatory guidelines and communicate updates
- Assist GRM/GSS as needed
- Prepare,
review and maintain IEC/IRB documentation
- Interact with IEC/IRB and site personnel
- Adapt country SIS/ISF to site needs and communicate country requirements to stakeholders
- Prepare and finalize CTAs, LOIs, budgets, and other site-level contracts
- Negotiate within approved templates and manage contract status
- Coordinate translations of final templates and contracts
- Obtain site and sponsor/Allucent signatures as applicable
- Maintain awareness of local regulations impacting contracts
- Prepare site-specific Essential Document Packages and ensure collection
- Coordinate with Global Essential Document Reviewer for document quality
- Follow up on document discrepancies until resolution
- Arrange Investigational Product shipment authorization
- Track start-up data in CTMS/Tracking tools
Requisiti fondamentali
- More than 2 years of experience in regulatory affairs in pharma/biotech
- Thorough knowledge of local submission and reporting requirements
- Strong understanding of the drug development process
- Fluent in Italian and English (oral and written)
- Attention to detail
- Team player
- Life Science degree or equivalent qualification
- Regulatory and ethics submission experience in a clinical setting
- Effective communication
- Team collaboration
- Attention to detail
- CTMS and (e)TMF management
- Regulatory submissions and documentation
- Clinical contract and budget negotiation