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.

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.

HOYA Group : Founded in 1941 in Tokyo, Japan, HOYA Corporation is a global technology and med-tech company and a leading supplier of innovative high-tech and medical products. HOYA’s divisions and business units research and develop products utilized in the healthcare and information technology fields. In the healthcare field, we provide medical device products such as eyeglasses, medical endoscopes, contact and intraocular lenses, orthopedic implants, surgical/therapeutic devices and medical device reprocessing and disinfection solutions. In the information technology field, we provide products such as optical lenses, photomasks and blanks used in the manufacturing process for semiconductor and LCD/OLED devices, text-to-speech, human resources and other software solutions and critical components for the mass memory and cloud storage industries. With over 150 offices and subsidiaries worldwide, HOYA currently employs a multinational workforce of 37,000 people.

HOYA Vision Care : As a global leader in optical technology, HOYA Vision Care is dedicated to providing innovative vision care solutions for every stage of a patient’s life. A steadfast partner to Eye Care Professionals around the world, it stands at the forefront of optical excellence. With a global presence, consisting of 43 laboratories and a growing team of 20,000 employees, HOYA Vision Care delivers innovative lenses and other vision care solutions to millions of people in 110 countries.

We focus on a better tomorrow, today. You can become part of our story. HOYA Vision Care is the place where you can act according to your strengths and evolve according to your aspirations. It’s a place where you can shape the way you work, guided by our CLEAR Values, and empowered by generations of expertise. You can get involved in our sustainability initiatives and choose to become a One Vision ambassador. You can give back the gift of sight to people all over the world by deciding to work with us.

We welcome people who challenge us to become better, who share our sense of purpose and who embrace growth so that our vision and mission align. We invite you to find out more, and together we can continue to provide vision for a lifetime.

Driven by a passion for partnership as well as innovation, HOYA has been a partner to Eye Care Professionals for over 75 years, enabling them to give people the greatest gift, the gift of vision. We provide Eye Care Professionals with the lenses, consultation solutions and other services that help them to develop their practice while changing the way people see the world. We see them as visionaries, and everything we do is for them. Founded in Japan in 1941, today, HOYA has a presence in over 80 countries across the globe.