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. Strong site startup, study management, and CRO oversight experience. Thorough understanding of ICH-GCP and clinical trial regulations. Excellent communication, organizational, and project management skills. Ability to work independently in a fast-paced environment. Preferred Experience in autoimmune, immunology, or related therapeutic areas. Experience conducting studies across Europe. Experience managing multicountry clinical trials. Prior oversight of large global CROs. Additional European language skills are a plus.