Clinical Operations Manager

At Ora, we are building the future of ophthalmic clinical research. As the world’s leading full-service ophthalmic drug and device development firm, we guide our clients across all phases of clinical research to efficiently bring new products and therapies to market. Over the past 45 years, our expert teams have helped earn more than 85 new product approvals. Ora’s pre-clinical and clinical models, unique methodologies, integrated clinical data solutions, and global regulatory strategies have been refined and proven across thousands of global projects. Today, our team continues to expand across the globe, with over 600 employees across North America, Europe, Asia, and Latin America.

The Role:

The Clinical Operations Manager is a key operational leader within the Clinical Monitoring organization, responsible for overseeing and optimizing Clinical Trial Associate (CTA) support activities across Ora clinical studies. This role serves as a liaison between CTA teams, CRAs, Project Managers, and Clinical Operations leadership to ensure efficient, compliant, and high-quality trial execution.

The role provides operational leadership, mentorship, training, process oversight, resource coordination, and continuous improvement support for CTA activities while driving operational excellence and inspection readiness.

What You’ll Do:

Clinical Trial Associate Operational Leadership

• Serve as the operational lead and subject matter expert for CTA functions within the Clinical Monitoring organization.
• Partner with Leadership to implement operational strategies, departmental objectives, and process improvements.
• Oversee resource forecasting and workload assessments for the CTA group.
• Provide functional leadership, guidance, mentoring, and day-to-day support to CTA staff.
• Support onboarding, training, and professional development initiatives for CTAs.
• Approve time reporting and expenses for direct reports.
• Act as an escalation point for CTA operational issues and collaborate with Monitoring leadership to resolve challenges.

Monitoring Operations Support

• Partner with Project Managers, CTMs, and CRAs to ensure CTA activities support project plans and study timelines.
• Monitor CTA-related performance metrics and operational indicators.
• Support inspection readiness and audit preparedness activities.
• Provide operational oversight of CTA deliverables to ensure quality and compliance.

Process Excellence and Continuous Improvement

• Lead initiatives focused on standardization, optimization, automation, and continuous improvement.
• Support development and maintenance of SOPs, work instructions, training materials, and operational tools.
• Promote effective utilization of CTMS, eTMF, and other clinical technologies.
• Identify operational risks and recommend solutions.

Study Oversight and Compliance

• Oversee CTA support activities related to study startup, maintenance, and closeout.
• Ensure study documentation and TMF activities remain complete and inspection-ready.
• Support compliance with sponsor requirements, SOPs, ICH-GCP guidelines, and regulations.

Additional Responsibilities

• Occasionally assist study projects where additional oversight of more junior team members is needed, or there is a need for more resources.
• Responsibilities may differ slightly from the above based on specific needs of the business.
• Clear and sustained demonstration of the Ora Clinical’s Values of prioritizing kindness, operational excellence, cultivating joy, and scientific rigor.