Director, Clinical Operations

The O'Connor Group

Director of Clinical Operations overseeing clinical studies in the United States while leading and mentoring clinical teams for operational excellence.

Posted 4/24/2026full-timeRemote • 🇺🇸 United StatesLeadWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Develop and implement clinical operations strategies to support the company's product pipeline, ensuring alignment with corporate goals and objectives
Lead and oversee the strategic planning, implementation and execution of clinical trials in accordance with project timelines, budget, and quality standards
Develop and manage comprehensive site management plans, including but not limited to, study protocols, clinical trial budgets, timelines, enrollment and risk mitigation strategies
Collaborate cross functionally with internal teams to ensure the alignment on clinical trial objectives and milestones and the successful execution and monitoring of clinical trials
Serve as the point of contact for CROs and vendors, overseeing their site management performance and ensuring adherence to contractual agreements, timelines and quality standards
Track accrued site operations and monitoring expenditure against the actual budget for each program
Ensure compliance with regulatory requirements, ICH-GCP requirements, and company SOPs throughout all stages of clinical trial conduct
Oversee the collection, analysis and interpretation of clinical trial data, working closely with Clinical Development, Biostatistics and Data Management teams to ensure data accuracy and integrity
In collaboration with the Head of Clinical Operations, hire, train, develop, and mentor the Clinical Operations/Clinical Research Associate team, fostering a culture of collaboration, accountability, continues improvement, and operational excellence
Identify and solve problems that may arise during the trial
Continuously evaluate and improve clinical trial processes

Requirements

What you’ll need

BS or BA (Life Sciences preferred) or certification in related allied health profession from an appropriately accredited institution
Minimum 10 years relevant clinical operations experience including demonstrated skills and competency in project management tasks
Broad knowledge of drug development process
Detailed knowledge of the following: Project management processes, Time and cost estimate development, ICH Guidelines and international regulatory requirements for clinical and site management
Experience managing: Multiple regions and/or vendors, Operational teams and clinical research associates
Excellent written and verbal communication skills, and planning and organization skills
Ability to negotiate and liaise with vendors in a professional manner

Benefits

Comp & perks

This job operated in a professional office environment
Required to work occasional nights and weekends to meet company demands

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

clinical operationsproject managementsite managementclinical trial designdata analysisrisk mitigationbudget managementregulatory complianceICH-GCPclinical trial monitoring

Soft Skills

leadershipcommunicationcollaborationproblem-solvingplanningorganizationmentoringaccountabilitycontinuous improvementnegotiation

Certifications

BS or BA in Life Sciencescertification in allied health profession