Clinical Operations Manager
New
Based in the United StatesFull-TimeManager
Salary not disclosed
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Job Details
- Languages
- Advanced English proficiency, both written and spoken.
- Experience
- Minimum of 5 years of experience in the clinical research industry
- Required Skills
- People ManagementResource PlanningMicrosoft Office
Requirements
- Advanced degree in Medicine, Pharmacy, Life Sciences, or a related field, or an equivalent combination of education, training, and experience.
- Minimum of 5 years of experience in the clinical research industry.
- Demonstrated people management or team leadership experience.
- Previous independent experience as an onsite Clinical Research Associate (CRA) is required.
- Experience managing, coaching, or mentoring clinical research professionals within a CRO, sponsor, or similar environment.
- Strong leadership, communication, coaching, and employee development skills.
- Experience with resource planning, workload management, and performance management processes.
- Solid knowledge of ICH-GCP guidelines, regulatory requirements, and clinical trial operations.
- Experience supporting audits, inspections, and quality improvement initiatives is preferred.
- Excellent organizational, analytical, and problem-solving capabilities.
- Proficiency with Microsoft Office tools and clinical research systems.
- Advanced English proficiency, both written and spoken.
- Ability to build trust, encourage collaboration, and create a positive team environment.
Responsibilities
- Lead, coach, mentor, and develop Clinical Research Associates across different levels of experience.
- Manage recruitment, onboarding, performance reviews, and ongoing professional development initiatives.
- Oversee resource allocation, workload planning, and team utilization across clinical studies.
- Partner with Project Managers and cross-functional teams to support successful study execution and resolve operational challenges.
- Monitor team performance using established operational metrics and implement actions to improve efficiency.
- Support the implementation of quality controls and contribute to the continuous improvement of clinical processes and systems.
- Prepare for and participate in audits, sponsor reviews, and regulatory inspections.
- Support feasibility activities for current and upcoming studies.
- Facilitate communication between project teams and investigational sites to ensure smooth trial operations.
- Contribute to business development activities through client discussions, networking opportunities, and operational input when needed.
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