Clinical Operations Manager

The Clinical Operations Manager is responsible for leading the planning, execution, oversight, and close-out of clinical studies that support the organization's research and development objectives. This role partners cross-functionally with internal teams and external stakeholders to ensure studies are conducted efficiently, ethically, and in compliance with applicable regulations, quality standards, and organizational goals.

The Clinical Operations Manager provides operational leadership throughout the clinical trial lifecycle, including study startup, execution, monitoring oversight, risk management, vendor management, budget oversight, and inspection readiness. Success in this role requires strong project management, collaboration, problem-solving, and communication skills in a dynamic and evolving environment.

Primary Responsibilities

Clinical Trial Planning and Execution

• Lead operational planning and execution of clinical studies from feasibility assessment and start-up through study closeout.
• Develop and maintain comprehensive study plans, timelines, milestones, budgets, and resource forecasts.
• Monitor study progress and ensure delivery against scope, schedule, quality, and budget objectives.
• Coordinate study activities across internal and external stakeholders to support successful trial execution.
• Anticipate operational challenges and implement solutions to maintain study timelines and quality standards.

Study Oversight & Vendor Management 

• Oversee day-to-day operational activities for assigned clinical studies.
• Serve as the primary operational contact for clinical sites, Contract Research Organizations (CROs), vendors, consultants, and external partners.
• Manage vendor selection, contracting, performance monitoring, and issue resolution.
• Establish clear expectations, performance metrics, and accountability with external partners.
• Escalate critical risks, issues, and deviations appropriately while driving timely resolution.

Regulatory Compliance and Quality Management

• Ensure studies are conducted in accordance with: 
  • FDA regulations (including 21 CFR Part 812 and Part 820, as applicable)
  • ISO 14155
  • ICH-GCP guidelines
  • Company policies, SOPs, and quality standards
• Support regulatory submissions and compliance activities throughout the study lifecycle.
• Lead or support audit and inspection readiness activities.
• Identify, assess, and mitigate study risks using a proactive risk management approach.
• Maintain inspection-ready documentation and oversight processes.