Site Startup Associate II

TL;DR

Site Startup Associate II (Clinical Trials): Preparing and submitting regulatory applications, EC/IRB submissions, and site contracts for clinical trial activation with an accent on interventional IMP studies and country-specific requirements. Focus on negotiating budgets, collecting essential documents, and ensuring Trial Master File compliance under EU regulations and CTIS.

Location: Portugal

Company

Global CRO helping biotech, medtech, and specialty pharma companies develop medicines, devices, and diagnostics.

What you will do

• Prepare and submit Central EC/IRB, local EC, RA applications, and other regulatory submissions.
• Handle ongoing submissions, amendments, safety reporting, and essential document collection/review.
• Negotiate site-specific investigator contracts and budgets from country templates.
• Conduct country-level site identification and feasibility processes.
• Prepare Investigational Product checklists per country regulations.
• Ensure Trial Master File accuracy with QC reviews.

Requirements

• Undergraduate degree in clinical, science, or health-related field or licensed healthcare professional.
• Experience as Site Startup Associate I or 5+ years in clinical trials, including 3+ years submitting via CTIS.
• Experience in contract and budget negotiation with sites.
• Knowledge of FDA Guidance, EU Directives/Regulations, local regs, ISO14155, drug/device development.
• Location: Portugal

Nice to have

• Experience with non-interventional studies, medical devices, GMO, observational studies.

Culture & Benefits

• Opportunities for growth, skill development, and work-life balance.
• Ideas and voice influence company work.
• Contract position: initial 6-month duration, 0.75 FTE.