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.
Documentation and Trial Master File Management
- Ensure completeness, quality, and accuracy of study documentation.
- Maintain oversight of Trial Master File (TMF) activities and document management processes.
- Review study records for compliance, consistency, and regulatory readiness.
- Contribute to the creation, implementation, and continuous improvement of clinical SOPs, templates, and operational processes.
Financial and Resource Management
- Develop, monitor, and manage clinical study budgets and forecasts.
- Track expenditures and identify opportunities to improve operational efficiency.
- Evaluate resource needs and collaborate with leadership to support study demands.
- Analyze operational performance metrics and provide recommendations for improvement.
Cross-Functional Collaboration
- Collaborate closely with Clinical Affairs, Regulatory Affairs, Quality, Research & Development, Biostatistics, Medical Affairs, and other functional teams.
- Facilitate effective communication among stakeholders to support alignment and execution.
- Contribute clinical operations expertise during study planning, protocol development, and strategic discussions.
- Support organizational initiatives that strengthen clinical research capabilities and operational excellence.
- 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.
- 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.
Qualifications
- Bachelor's degree in Life Sciences, Health Sciences, Nursing, Biomedical Engineering, Public Health, or related discipline; equivalent combinations of education and relevant experience will also be considered.
- Five or more years of experience managing clinical studies, clinical operations programs, or related research initiatives within the medical device, biotechnology, pharmaceutical, or CRO environment.
- Working knowledge of applicable clinical research regulations and standards, including FDA regulations, ISO 14155, and ICH-GCP.
- Experience managing external vendors, CROs, and study partners.
- Demonstrated project management and operational leadership experience.
- Advanced degree (Master's, PhD, MPH, or equivalent) in a relevant field.
- Experience supporting medical device clinical investigations.
- Experience participating in regulatory inspections and audits.
- Certification in clinical research, project management, or related disciplines (e.g., CCRP, CCRA, PMP).
Preferred Qualifications
- Advanced degree (Master's, PhD, MPH, or equivalent) in a relevant field.
- Experience supporting medical device clinical investigations.
- Experience participating in regulatory inspections and audits.
- Certification in clinical research, project management, or related disciplines (e.g., CCRP, CCRA, PMP).
Leadership Attributes
Drives Results
Consistently achieves objectives and delivers high-quality outcomes by establishing priorities, maintaining accountability, and overcoming obstacles.
Plans and Aligns
Develops clear plans, coordinates resources effectively, and aligns stakeholders around common goals and timelines.
Manages Complexity
Navigates ambiguity, balances competing priorities, and makes sound decisions in complex operational environments.
Collaborates
Builds strong partnerships across functions, organizations, and external stakeholders to achieve shared objectives.
Communicates Effectively
Delivers information clearly and concisely while adapting communication approaches across audiences and situations.
Ensures Accountability
Holds self and others accountable for commitments, quality standards, compliance requirements, and operational outcomes.
Resourcefulness
Secures and deploys resources effectively while finding creative solutions to operational challenges.
Decision Quality
Makes timely, informed decisions by integrating data, experience, regulatory requirements, and business considerations.
Situational Adaptability
Demonstrates agility and resilience in response to changing priorities, evolving study needs, and organizational growth.
Builds Effective Teams
Fosters collaboration, trust, inclusion, and high performance among project team members and external partners.
Instills Trust
Acts with integrity, transparency, and professionalism while maintaining credibility with internal and external stakeholders.
Optimizes Work Processes
Continuously improves systems, procedures, and workflows to enhance operational efficiency, quality, and compliance.