Start-Up Associate II (Clinical Trials, Madrid)

About the role

Allucent helps small-to-medium biopharmaceutical companies navigate clinical trials. It is looking for a Start-Up Associate II (SUA II) to join its A-team in Madrid, Spain, in a hybrid setting. The role coordinates and carries out 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 colleagues file documents they own
• 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 to the site
• Support the Global Regulatory Manager and Global Submission Specialist, and keep track of regulatory updates

Required profile

• Degree in Life Sciences or equivalent qualification in a related allied health profession
• More than 2 years of experience in regulatory affairs in the pharmaceutical or biotechnology industry
• Fluent Spanish and English, with good oral and written communication skills
• Attention to detail and ability to work well as part of a team

Required skills

• Knowledge of local competent authority submission and reporting requirements
• Understanding of the drug development process
• Use of CTMS and (e)TMF

What we offer

• Comprehensive benefits package and competitive salary per location
• Departmental study and training budget
• Flexible working hours within reason, and a Buddy Program for new and existing employees
• Internal growth opportunities, an employee referral program and award programs for performance and loyalty