Site Activation Manager – Clinical Study Start‑Up

About the role

The Site Activation Manager leads the strategic planning and execution of site activation activities for clinical studies. This includes overseeing site identification, ethics and regulatory submissions, and contract negotiations to ensure rapid patient enrollment.

Key responsibilities

• Develop and maintain a Site Activation Management Plan aligned with the project scope and timeline.
• Coordinate pre‑award, bid defense, and start‑up activities across multiple regions or globally.
• Manage regulatory submissions, approvals, and contract negotiations in compliance with ICH‑GCP and internal policies.
• Provide regular updates and reporting to study teams and senior leadership.
• Maintain internal systems, databases, and tracking tools with accurate project information.
• Mentor junior colleagues and foster long‑term stakeholder relationships.

Required profile

• Proven experience in clinical site activation, regulatory affairs, or related project management.
• Strong understanding of ICH‑GCP guidelines and regulatory landscapes.
• Ability to communicate effectively with internal and external stakeholders across regions.
• Detail‑oriented with a track record of delivering projects on time and within scope.

Required skills

• ICH‑GCP compliance
• Regulatory submission and approval processes
• Project management