Position Summary:
The Clinical Operations Manager is responsible for the planning, execution, oversight, and successful delivery of clinical research projects on behalf of sponsor clients. This role ensures studies are conducted in compliance with applicable regulations, Good Clinical Practice (GCP), sponsor requirements, and company Standard Operating Procedures (SOPs). The Clinical Operations Manager provides leadership to cross-functional teams, manages timelines and budgets, and serves as the primary operational contact for sponsors and study sites.
Clinical Trial Management:
Lead the operational management of Phase I–IV clinical trials from study start-up through closeout.
Develop and maintain project timelines, study plans, and operational metrics.
Monitor study progress to ensure milestones, enrollment goals, and deliverables are achieved.
Identify operational risks and implement mitigation strategies.
Coordinate cross-functional activities across clinical monitoring, data management, regulatory affairs, medical writing, pharmacovigilance, and vendors.
Sponsor & Client Management:
Serve as the primary operational liaison between sponsors and internal project teams.
Lead sponsor meetings, provide regular study updates, and prepare project status reports.
Build and maintain strong client relationships while ensuring high levels of customer satisfaction.
Manage project scope and support change order discussions when necessary.
Site Management Oversight:
Oversee site selection, activation, monitoring, and closeout activities.
Ensure Clinical Research Associates (CRAs) are appropriately supported and managed.
Review site performance metrics and implement corrective actions as needed.
Assist with site escalation and issue resolution.
Regulatory & Quality Compliance:
Ensure studies comply with ICH-GCP guidelines, FDA regulations, local regulatory requirements, and company SOPs.
Support inspection readiness and participate in sponsor audits and regulatory inspections.
Review essential study documentation for completeness and quality.
Promote continuous quality improvement initiatives.
Financial & Resource Management:
Assist in developing and managing study budgets.
Track project financial performance and resource utilization.
Forecast staffing needs and coordinate resource allocation.
Review vendor performance and budget adherence.
Team Leadership:
Lead multidisciplinary project teams to ensure effective collaboration.
Mentor Clinical Research Associates and Clinical Trial Assistants.
Support employee development through coaching and performance feedback.
Foster a culture of accountability, quality, and continuous improvement.
Reporting & Metrics:
Prepare operational reports, KPIs, enrollment dashboards, and study performance metrics.
Present project updates to senior leadership and sponsor teams.
Monitor quality indicators and implement process improvements.
Qualifications:
EducationBachelor's degree in Life Sciences, Nursing, Pharmacy, Public Health, or a related field required. Master's degree preferred.****Thank you for your interest in this opportunity! Due to the high volume of applications we receive, we are unable to respond to every applicant individually. If you do not hear from us regarding this role, it means we have moved forward with other candidates at this time. We sincerely appreciate your interest and encourage you to apply for future opportunities that match your experience and career goals.
