Clinical Monitoring Lead overseeing CRO activities for clinical trials at Excelya. Coordinating efforts across study phases while ensuring compliance and quality standards in a hybrid work environment.
About the role
- Manager of Clinical Operations overseeing teams in clinical trial execution and operational excellence. Driving high performance in clinical operations staff to transform patient impact worldwide.
Responsibilities
- Lead a team that transforms clinical trial execution into measurable impact for patients worldwide
- Provide strategic oversight and line management of clinical operations staff
- Ensure high performance and professional development of clinical operations staff
- Drive operational excellence across clinical trial execution
- Define and track performance metrics such as site visits, milestone completion, and data quality
- Conduct co-monitoring and quality visits with CRAs to ensure quality oversight and protocol adherence
- Collaborate with cross-functional teams to align on resourcing, study priorities, timelines, and operational execution
- Embed Risk-Based Quality Management principles within the clinical operations team
- Ensure all clinical operations activities comply with ICH-GCP, applicable regulations, and internal SOPs
Requirements
- 4+ years' experience in clinical trial management and people management within the pharmaceutical industry or CRO environment
- A Bachelor's degree in life sciences or related field (Master's degree preferred)
- Strong track record in designing and implementing clinical trial strategies that align with organizational goals and regulatory requirements
- Proven experience leading multi-functional clinical teams, providing training oversight, and fostering collaboration to achieve clinical development objectives
- Demonstrated ability to ensure high-quality execution of clinical trial activities in compliance with ICH-GCP, regulatory requirements, and internal SOPs
- Strong project management capabilities including the ability to manage multiple clinical trials simultaneously while meeting timelines, budgets, and quality standards
- Excellent communication skills with the ability to engage internal and external stakeholders at all organizational levels with clarity and impact
- Analytical and critical thinking skills to solve complex problems and drive practical solutions that improve trial design and execution
- Flexibility to travel to sites to perform in-field co-visits, ensuring high-quality operational training and support for clinical teams
Benefits
- Professional development
- Opportunities to learn and develop
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