Clinical Operations Manager

HOYA Surgical Optics

. Lead operational planning and execution of clinical studies from feasibility assessment and start-up through study closeout .

Posted 10/13/2026full-timeLewisville • Texas • United StatesMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing clinical studies and operational planning, ensuring compliance with FDA regulations, ISO 14155, and ICH-GCP guidelines. Proven ability to lead cross-functional collaboration and vendor management while maintaining high-quality standards and operational efficiency.

Highest-signal resume keywords

Clinical Study ManagementFDA Regulations KnowledgeProject Management ExperienceVendor ManagementRegulatory Compliance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical OperationsStudy PlanningBudget ManagementRisk MitigationPerformance Monitoring

Soft Skills

CollaborationProblem-SolvingCommunicationLeadership

Certifications & Qualifications

CCRPCCRAPMP

Industry Keywords

Medical DeviceBiotechnologyPharmaceuticalCROICH-GCP

Tech Stack

Tools & technologies

PMP

About the role

Key responsibilities & impact

Lead operational planning and execution of clinical studies from feasibility assessment and start-up through study closeout
Develop and maintain study plans, timelines, milestones, budgets, and resource forecasts
Monitor study progress against scope, schedule, quality, and budget objectives
Coordinate study activities across internal and external stakeholders
Anticipate operational challenges and implement solutions to maintain timelines and quality standards
Oversee day-to-day operational activities for assigned clinical studies
Serve as primary operational contact for clinical sites, CROs, vendors, consultants, and external partners
Manage vendor selection, contracting, performance monitoring, and issue resolution
Establish expectations, performance metrics, and accountability with external partners
Escalate and resolve critical risks, issues, and deviations
Ensure compliance with FDA regulations, ISO 14155, ICH-GCP, company policies, SOPs, and quality standards
Support regulatory submissions, audits, inspections, and inspection readiness
Identify, assess, and mitigate study risks
Maintain complete, accurate, and inspection-ready study documentation and Trial Master File activities
Improve clinical SOPs, templates, and operational processes
Develop, monitor, and manage clinical study budgets and forecasts
Track expenditures and identify operational efficiency improvements
Evaluate resource needs and analyze operational performance metrics
Collaborate with Clinical Affairs, Regulatory Affairs, Quality, Research & Development, Biostatistics, Medical Affairs, and other teams
Contribute clinical operations expertise to study planning, protocol development, and strategic discussions
Support initiatives that strengthen clinical research capabilities and operational excellence

Requirements

What you’ll need

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 FDA regulations, including 21 CFR Part 812 and Part 820, as applicable
Working knowledge of ISO 14155 and ICH-GCP guidelines
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, such as CCRP, CCRA, or PMP
Strong project management, collaboration, problem-solving, and communication skills
Ability to work with Clinical Affairs, Regulatory Affairs, Quality, Research & Development, Biostatistics, Medical Affairs, and other functional teams

Benefits

Comp & perks

Hybrid work arrangement
Opportunity to work for HOYA Group, a global technology and med-tech company
Professional growth and development opportunities
Sustainability initiatives and One Vision ambassador opportunities
Opportunity to contribute to vision care solutions serving people worldwide