Start-Up Associate II (Italy)

Allucent; United States; Hybrid; USD 45,000 - 68,000; Full time

Benefits offered by this job

Comprehensive benefits package

Flexible working hours

Buddy Program and career development

Growth opportunities

Job summary

Allucent is seeking a Start-Up Associate II to coordinate local site start-up activities and regulatory submissions across Italy. The role acts as the main liaison with RA/IEC/IRB and site investigators during the initial phase of a clinical study until Site Initiation Visit.

The candidate will manage document collection, eTMF filing, and preparation of regulatory documentation, while ensuring compliance with local regulations and timelines.

Qualifications

• 2+ years in regulatory affairs in pharma/biotech
• Excellent communication in Italian and English
• Strong understanding of country/region regulatory submissions and guidelines
• Thorough knowledge of drug development process
• Detail-oriented with ability to work in a team

Responsibilities

• Coordinate local site start-up activities and regulatory submissions.
• Manage document collection and eTMF filing as document owner.
• Interact with RA/IEC/IRB and investigators across initial phase of study.
• Prepare and review Clinical Trial Agreements (CTAs), budgets, and site contracts.
• Track milestones and updates in CTMS and share with study teams.
• Ensure updates are communicated and compliant with local regulations.

Skills

Regulatory affairs experience

Life science degree

Attention to detail

Fluent in Italian

Fluent in English

Team player

Regulatory knowledge

Education

Life Science degree or equivalent qualification

Job description

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.

We are looking for a Start-Up Associate II (SUA II) to join our A-team (hybrid*/remote) in Italy! The SUA coordinates and performs local site start-up activities of Allucent Study Start-up & Site Intelligence. This position executes essential document collection, Regulatory Authority (RA) and Independent Ethics Committee (IEC)/Institutional Review Board (IRB) submission/approval activities and acts as a main line of communication to RA/ IEC/ IRB as well as investigators and sites through the initial phase of a clinical study until the Site Initiation Visit.

In this role your key tasks will include:

• Track relevant information, data, progress and milestones in CTMS and/or other tracking tools covering assigned Start-Up activities (as defined below)
• Ensure planned dates are reliable and up to date in CTMS departments/study teams
• File documents in the (e)TMF for which they are the document owner
• Assist other Study Start-up team members with filing documents in the (e)TMF for which they are document owner
• Assist in the preparation, compilation, submission and maintenance of regulatory documentation required by regulatory agencies for clinical trials at local level
• Provide relevant documents in compliance with local regulation
• Support review of technical, pre-clinical and clinical reports for regulatory submissions
• Interact with regulatory authorities
• Prepare and compile answers for questions raised by the regulatory agencies and submit the answers
• Regularly check for updates on regulations, guidelines and procedures. Ensure these updates are communicated and circulated as appropriate
• Support Global Regulatory Manager (GRM) and/or Global Submission Specialist (GSS) as needed
• Prepare, compile, submit and maintain ethical requirements and documentation required by IEC/IRB for clinical trials at local level
• Assist in providing and reviewing relevant documents in compliance with ethical requirements and per local legislation
• Interact with IEC/IRB
• Prepare and compile answers for questions raised by the IEC/IRB and submit the answers
• Regularly check for updates on regulations, guidelines, and procedures. Ensure these changes and updates are communicated and circulated as appropriate
• Assist in adapting country SIS/ISF to site-specific requirements
• Provide country specific requirements to GSCM impacting site contracts’ process
• Prepare, review, negotiate, and finalize Clinical Trial Agreements (CTAs), Letter of Indemnification (LOI), termination letters, budgets, and other site level agreements required for a clinical study
• Negotiate within client approved contract and budget templates and negotiation parameters
• Communicate with sites and internal personnel regarding the status of contracts and contract related documents
• Arrange translation of the final country CTA template and/or final negotiated contracts, where applicable
• Provide the final/draft CTA and site budget for submission, where required
• Obtain site signature as well as Sponsor/Allucent signature, as applicable
• Keep up to date with applicable local regulations impacting clinical trial contracts
• Assist in preparing the site-specific Essential Document Package and sending to sites
• Responsible for collection and first review of Essential Documents
• Provide the Global Essential Document Reviewer with the collected documents for independent review
• Follow up with the sites regarding all document discrepancies noted by the Global Essential Document Reviewer until resolution
• Obtain authorization for the shipment of Investigational Product to the site
• Track relevant information and data in CTMS and/or other tracking tools

Requirements

To be successful you will possess:

• Life Science degree or equivalent qualification or certification in a related allied health profession from an appropriate accredited institution.
• More than 2 years of experience in regulatory affairs in the pharmaceutical or biotechnology industry.
• A thorough knowledge of the country or region competent authority submission and reporting requirements and guidelines.
• A thorough understanding of the drug development process
• Good oral and written communications skills - fluent in Italian and English.
• Attention to detail.
• Able to perform well as a team member.

Benefits

Benefits of working at Allucent include:

• Comprehensive benefits package per location
• Competitive salaries per location
• Departmental Study/Training Budget for furthering professional development
• Flexible Working hours (within reason)
• Participation in our enriching Buddy Program as a new or existing employee
• Internal growth opportunities and career progression
• Financially rewarding internal employee