About This Role
This Senior Clinical Operations Manager role involves leading and overseeing Clinical Operations personnel, including Clinical Research Associates and Clinical Trial Managers. The position focuses on ensuring high-quality, compliant, and efficient clinical monitoring and trial management services, providing strategic oversight, coaching, and quality governance. It suits an experienced Clinical Trial Manager leader passionate about developing high-performing teams and driving clinical trial management excellence.
Responsibilities
- Ensure clinical monitoring and trial management activities of assigned teams are performed to the Sponsor’s satisfaction, ensuring timely high-quality deliverables, within budget, and in accordance with applicable standard operating procedures (SOPs), regulations, good clinical practices, and study-specific requirements
- Provide line management and performance oversight for Clinical Operations personnel, including Clinical Research Associates (CRAs), Clinical Trial Managers (CTMs), and other roles, ensuring they meet performance objectives aligned with departmental goals, study requirements, and company strategy, and taking appropriate remedial actions as required
- Support the hiring, onboarding, training, development, retention, and succession planning of Clinical Operations personnel, providing coaching and mentorship
- Assist in developing, delivering, and overseeing training programs and ensure consistent adoption of SOPs, tools, and systems
- Oversee resource planning and allocation across studies to ensure appropriate staffing and workload balance
- Track Clinical Operations metrics and monitor adherence to targets, including performance trends and capacity planning
- Ensure Clinical Operations activities are executed in accordance with approved study budgets and monitor utilization and financial performance
- Partner with Project Management and Finance to identify risks and implement mitigation strategies
- Perform or oversee Quality Assessment Visits (QAVs) and site visit report reviews
- Identify risks and quality issues and ensure implementation of corrective and preventive actions
- Serve as escalation point for Clinical Operations teams, sponsors, and stakeholders
- Drive innovation and continuous improvement, including adoption of technology and AI-enabled solutions
- Employee may be assigned to other responsibilities that do not pertain to their former description, if they have the required experience, are qualified and/or have received adequate training
Requirements
- Bachelor’s Degree in a field relevant to clinical research
- Minimum 10 years of clinical research experience in the biotechnology, pharmaceutical, or CRO industry, including monitoring and senior operational oversight as a Clinical Operations Manager, Project Manager, Clinical Trial manager, or equivalent job role
