Associate Director Clinical Operations (Consultant)

Position Summary

We are seeking an experienced Associate Director, Clinical Operations to lead the execution of a multinational Phase 2/3 clinical study. This individual will serve as the operational lead for the trial, partnering with cross-functional teams, investigators, and CROs to ensure successful study startup, execution, and closeout.

The ideal candidate is a hands‑on clinical operations leader with experience managing global studies, driving site startup activities, and overseeing CRO performance. This role requires strong project management skills, the ability to operate independently, and a proactive approach to identifying and mitigating study risks.

Key Responsibilities

• Lead clinical trial execution from startup through closeout.
• Manage study timelines, milestones, and operational deliverables.
• Drive site identification, selection, activation, and enrollment strategies.
• Oversee CRO and vendor performance to ensure quality and timeline adherence.
• Collaborate with Clinical Development, Data Management, Biostatistics, Medical Monitoring, Regulatory, and other cross-functional teams.
• Identify operational risks and develop mitigation strategies.
• Track study progress and provide regular updates to leadership.
• Ensure compliance with GCP, SOPs, and applicable regulatory requirements.
• Support investigator and site relationship management throughout the study lifecycle.

Qualifications

Required

• Bachelor’s degree in Life Sciences or related discipline.
• Significant Clinical Operations experience within the biotechnology, pharmaceutical, or CRO industry.
• Experience leading Phase 2 and/or Phase 3 clinical trials.
• Proven success managing global or regional clinical studies.