Associate Director, Clinical Operations (Consultant)

Job Details

Posted 6 October, 2026

Job Id: 631374

Location

Boston, Massachusetts

Category: Clinical Development and Operations

Salary

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Country: United States

Employment: Contract

Worksite: On-Site

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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.

Equal Opportunity Employer

We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us(opens in new tab) directly so that we can explore the appropriate arrangements.

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