The global CRO where clinical trials run on time.
Clinical Operations Manager
Location
United States
Posted
2 days ago
Salary
0
Seniority
Senior
Job Description
Clinical Operations Manager
PSI CRO AG
• Line manage, coach, mentor, and develop Clinical Research Associates across multiple experience levels. • Manage hiring, onboarding, performance management, and professional development activities. • Oversee resource allocation, workload planning, and utilization across clinical trials. • Collaborate with Project Managers and cross-functional teams to ensure successful study delivery. • Monitor staff performance and support operational efficiency through established departmental metrics. • Implement departmental quality controls and contribute to the development and continuous improvement of quality systems and processes. • Prepare for and participate in internal audits, sponsor audits, and regulatory inspections. • Support trial execution by resolving operational challenges and facilitating communication between project teams and investigational sites. • Participate in feasibility assessments for new and ongoing studies. • Support business development activities, including client meetings, networking events, and operational discussions, as needed.
Job Requirements
- MD, PharmD, or a university degree in Life Sciences, or an equivalent combination of education, training, and experience.
- Minimum of 5 years of clinical research industry experience, including demonstrated team management or people leadership experience.
- Previous experience working independently as an onsite Clinical Research Associate (CRA) is required.
- Previous experience managing or mentoring clinical research professionals in a CRO, sponsor, or related clinical research environment.
- Strong leadership, coaching, and employee development skills.
- Experience with resource planning, workload management, and performance management.
- Working knowledge of ICH-GCP, applicable regulatory requirements, and clinical trial operations.
- Experience supporting audits, inspections, and quality initiatives is preferred.
- Excellent communication, organizational, and problem-solving skills.
- Proficiency with Microsoft Office applications and clinical research systems.
- Advanced English proficiency (written and spoken).
- Strong interpersonal skills with the ability to build trust, foster collaboration, and develop high-performing teams.
Benefits
- All your information will be kept confidential according to EEO guidelines
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