Senior Site Activation Specialist (Copenhagen) Hybrid

About the role

Senior Site Activation Specialists ensure high‑quality deliverables for clinical trial start‑up activities at the country level, supporting site activation and first patient in timelines. The role works with cross‑functional teams, sponsors and regulatory authorities to drive efficient trial initiation.

Key responsibilities

• Prepare and submit local and central ethics committee applications, regulatory authority submissions, and manage ongoing amendments and notifications.
• Monitor project timelines, financial aspects, and milestone progress, providing contingency plans and escalating issues as needed.
• Maintain trial master file documentation, ensure SOP/WI compliance, and drive continuous improvement of site start‑up processes.
• Act as subject‑matter expert for country‑level start‑up intelligence, providing regulatory guidance and supporting internal training material creation.

Required profile

• Bachelor’s degree with solid understanding of clinical trial phases II‑IV and ICH GCP.
• Proven experience in clinical trial start‑up, project management in a fast‑paced environment, and vendor management.
• Strong organizational, communication, negotiation and problem‑solving skills, with ability to mentor junior staff.

Required skills

• ICH GCP compliance
• Clinical trial start‑up processes
• Regulatory submission preparation
• Project management
• Vendor management