Clinical Operations Manager

HOYA Group•Lewisville, TX

20h

About The Position

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.

Requirements

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.

Nice To Haves

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).

Responsibilities

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.
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.
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.
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.
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.