Site Start Up Associate II (Clinical Research)

TL;DR

Site Start Up Associate II (Clinical Research): Managing regulatory submissions and site activation for biotech and pharma companies with an accent on CTIS submissions and contract negotiation. Focus on ensuring compliance with FDA/EU regulations and managing the Trial Master File (TMF) throughout the study lifecycle.

Location: Portugal

Company

A global contract research organization (CRO) helping biotech, medtech, and specialty pharma companies transform breakthrough science into new medicines and diagnostics.

What you will do

• Prepare and submit Central EC/IRB, Local EC, and RA applications to regulatory authorities and hospitals.
• Manage ongoing submissions, amendments, and periodic safety notifications.
• Negotiate site-specific contracts and budgets from country templates.
• Conduct site identification and feasibility processes at the country level.
• Develop Investigational Product (IP) checklists in accordance with country regulations.
• Perform QC reviews to ensure the accuracy and completeness of Trial Master File (TMF) documents.

Requirements

• Undergraduate degree in a clinical, science, or health-related field.
• Proven experience as a Site Start Up Associate I or 5+ years of related clinical trials experience.
• At least 3 years of experience in clinical trial applications via CTIS.
• Experience in contract and budget negotiation with clinical sites.
• Working knowledge of FDA Guidance, EU Directives/Regulations, and ISO14155.
• Must be based in Portugal.

Culture & Benefits

• Support for professional growth and skill development.
• Emphasis on flexibility and work-life balance.
• Inclusive environment where individual ideas influence company workflows.
• Opportunity to contribute to the delivery of life-saving medical innovations.