Clinical Operations Manager
PSI CRO AG, United States, NY, Remote
Clinical OperationsOther Advanced RequiredSenior
About the role
Company Description
PSI is a leading Contract Research Organization with more than 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.
Job Description
PSI 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.
About PSI CRO AG
PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas. PSI is known in the industry as a CRO focused on ‘on-time project delivery’. This is achieved through investing substantial effort and MD resources into performing quality feasibility assessments that provide an accurate predictor of study timelines. PSI’s global reach allows us to run clinical trials across multiple continents, in 50+ countries around the world. PSI’s reputation is that of a 'no-nonsense' CRO focused on timely patient enrollment and project delivery. An exceptionally high repeat and referral business rates alongside low staff turnover are indicative of our commitment to be the best CRO in the world as measured by our clients and our employees. http://www.psi-cro.com