Start-Up Associate II
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In this role you support local study start-up activities for clinical trials, acting as the primary liaison with regulatory bodies and ethics committees through site initiation. You manage regulatory documentation, eTMF/CTMS filing, and site contracts to ensure timely, compliant start-up. You collaborate with cross-functional teams to address questions from authorities and sites, keeping regulatory and ethical requirements up to date. This is a hands-on role at the start of a study that shapes site readiness and study execution.
Retribuzione / Benefits- Comprehensive benefits package per location
- Competitive salaries per location
- Training budget for professional development
- Flexible working hours
- Buddy program for newcomers
- Internal growth opportunities and career progression
- Coordinate local start-up activities and maintain trackers in CTMS or similar tools
- File and own documents in the (e)TMF and assist team members with filings
- Prepare, compile, submit and maintain regulatory documentation for local trials
- Interact with regulatory authorities and respond to questions
- Prepare and compile ethical submissions to IEC/IRB and address inquiries
- Assist in adapting country SIS/ISF to site requirements and support contract processes
- Prepare, review and finalize CTAs, LOIs, budgets, and site-level agreements
- Obtain necessary signatures and ensure documentation complies with local regs
- Prepare Essential Document Package and liaise with Global Reviewer
- Track Investigational Product shipment authorization and status
- Life Science degree or equivalent
- >2 years of regulatory affairs experience in pharmaceutical/biotech
- Strong knowledge of local submission and reporting requirements
- Understanding of the drug development process
- Fluent Italian and English oral/written communication
- Attention to detail and teamwork
- excellent written and verbal communication
- attention to detail
- team player
- CTMS tracking
- (e)TMF document management
- regulatory submissions and interactions with authorities
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