Start-Up Associate Contractor (Bulgaria)

About the role

Allucent helps small-to-medium biopharmaceutical companies navigate clinical trials. It is looking for a Start-Up Associate Contractor (SUA) to join its A-team in Sofia, working up to 0.5 FTE in a hybrid or remote setup. The SUA coordinates and carries out local site start-up activities for Allucent's Study Start-up and Site Intelligence, acting as the main contact with regulatory authorities, ethics committees, investigators and sites during the early phase of a clinical study, until the Site Initiation Visit.

Key responsibilities

• Track start-up progress and milestones in CTMS and other tools, and keep planned dates current
• File documents in the (e)TMF and help colleagues file documents they own
• Prepare, compile and submit regulatory documentation and interact with regulatory authorities, answering their questions
• Support review of technical, pre-clinical and clinical reports for regulatory submissions
• Prepare and submit ethical documentation for IEC/IRB approval and answer their questions
• Help adapt the country SIS/ISF to site needs, prepare and negotiate Clinical Trial Agreements, LOIs, budgets and other site-level agreements, and obtain signatures
• Collect and review Essential Documents, follow up on discrepancies until resolved, and track shipment authorisation for the investigational product
• Support the Global Regulatory Manager and Global Submission Specialist as needed

Required profile

• Life science degree or equivalent qualification in a related allied health profession
• More than 5 years of regulatory affairs experience in pharma or biotechnology
• Experience with contract negotiation
• Fluent Bulgarian and English, good oral and written communication, attention to detail and teamwork