Start-Up Associate Contractor (Spain)

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 Barcelona, working 0.5 FTE on a hybrid or remote basis. The SUA coordinates and performs local site start-up activities for Allucent's Study Start-up and Site Intelligence function, 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 in CTMS
• File documents in the (e)TMF and help other team members do so
• Prepare, compile and submit regulatory documentation for local regulatory agencies, and prepare answers to their questions
• Review technical, pre-clinical and clinical reports for regulatory submissions and interact with regulatory authorities
• Prepare ethical documentation for IEC/IRB, answer their questions and adapt country SIS/ISF to site needs
• Negotiate and finalise Clinical Trial Agreements, Letters of Indemnification, budgets and other site-level agreements, and obtain site and sponsor signatures
• Collect and review Essential Documents, follow up on discrepancies and authorise shipment of 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 Spanish and English, with good oral and written communication skills
• Attention to detail and ability to work as part of a team