Job DescriptionPSI is seeking an experienced and people-focused Clinical Operations Manager to join our team.
In this leadership role, you will be responsible for the management, development, and operational oversight of CRA staff. You will lead and mentor a high-performing team while ensuring efficient resource utilization, operational excellence, and the successful delivery of clinical trials. This position requires a collaborative leader who is passionate about developing people, driving quality, and partnering across functions to support study execution.
This is a home-based role based in the United States.
The scope of responsibilities will include:- 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.
Qualifications- 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.
Additional InformationAll your information will be kept confidential according to EEO guidelines.
