Site Activation Specialist (SSU/RSU)

About the role

The Site Activation Specialist supports country‑level site activation activities for clinical studies, ensuring compliance with local and international regulations, SOPs, and project timelines. The role acts as the single point of contact for investigative sites, the Site Activation Manager, and project teams.

Key responsibilities

• Serve as the Single Point of Contact (SPOC) for assigned studies, coordinating with sites, SAM, and project teams.
• Execute start‑up and site activation tasks according to regulations, SOPs, and work instructions.
• Prepare, review, and distribute regulatory documents, ensuring completeness and accuracy.
• Maintain internal systems, databases, and tracking tools with up‑to‑date project information.
• Monitor site performance metrics and provide feedback to management.
• Track and follow up on the approval and execution of ethics, ICF, and Investigator Pack documents.
• Provide local expertise during project planning and timeline development.
• Perform quality control of site‑provided documents and may liaise directly with sponsors on specific initiatives.

Required profile

• Bachelor’s degree in life sciences or related field.
• Minimum 3 years of clinical research experience, including at least 1 year in a leadership capacity.
• Strong knowledge of GCP/ICH, local regulatory requirements, and corporate standards.
• Excellent communication, organizational, and interpersonal skills.
• Ability to work independently, prioritize tasks, and manage multiple projects.