Start-Up Associate II

1 giorno fa

monzabrianza, lombardia, Italia Allucent Tempo pieno

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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 Bonus 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

Start-Up Associate II

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Start-Up Associate II

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