Site Activation Specialist I

About the role

The Site Activation Specialist I will support the launch of clinical trials at the country level, ensuring all regulatory and operational requirements are met. Working closely with the SSU Country Manager and the start‑up team, you will help drive timely submissions and maintain high‑quality deliverables for our clients.

Key responsibilities

• Provide quality deliverables in accordance with project requirements and local regulations, under the guidance of the SSU Country Manager.
• Track and manage forecasted submission and approval timelines using the SSU tracking system; report delays, develop contingency plans and escalate issues promptly.
• Monitor basic financial aspects of the project, including contract hours and tasks, and raise discrepancies as needed.
• Ensure compliance with Standard Operating Procedures (SOPs) and Work Instructions (WIs), keep training records up‑to‑date and guarantee timesheet accuracy.
• Submit all required documents to the Trial Master File (TMF) following company and sponsor SOPs.
• Support local submission activities by following direction from the Country Start‑up Advisor (CSA) and Study Activation Manager (SAM), acting as a point of contact when required.

Required profile

• Strong attention to detail and ability to work within defined timelines.
• Good understanding of clinical trial start‑up processes and country‑specific regulatory requirements.
• Basic financial awareness to track contract hours and tasks.
• Ability to follow SOPs, maintain accurate records and ensure compliance.
• Effective communication skills to coordinate with internal teams and external stakeholders.

Required skills