Regulatory & Startup Specialist (Country Level)

About the role

This position supports country‑level site activation (SA) activities for clinical research studies. Working remotely, you will act as the single point of contact for investigative sites, the Site Activation Manager, and project teams, ensuring compliance with local and international regulations.

Key responsibilities

• Serve as the Single Point of Contact (SPOC) for assigned studies, coordinating with sites, SAM, and project management.
• Execute start‑up and site activation tasks in line with SOPs, work instructions, and regulatory requirements.
• Prepare, review, and distribute regulatory documents, ensuring completeness and accuracy.
• Maintain internal systems, databases, and tracking tools with up‑to‑date project information.
• Monitor project timelines, establish contingency plans, and report site performance metrics.
• Track approval and execution of ethics, ICF, and Investigator Pack documents.
• Provide quality control of site‑provided documents and support SAMs during planning phases.
• Interact with sponsors on specific initiatives when required.

Required profile

• Experience in regulatory and site activation activities within clinical research.
• Familiarity with SOPs, work instructions, and regulatory guidelines.
• Ability to work independently in a remote setting and manage multiple stakeholder relationships.
• Strong organizational skills for document tracking and timeline management.

Required skills

What we offer

• Opportunity to work with a global leader in clinical research services.
• Remote work flexibility.
• Collaboration with multidisciplinary teams across the life‑sciences industry.