Summary

Cecile Glairet, has acquired extensive experience of the pharmaceutical industry. This includes 7 years of Clinical Research experience as well as 2 years of early drug development experience. This experience was acquired mainly in a large pharmaceutical company environment: site management (starting as CRA), process management, internal and external training (as Clinical Process Manager). She has demonstrated capabilities to adapt to new culture and new projects and is currently working as a consultant for a leading Contract Research Organisation.

As a Lead CRA/Team Lead, Cecile:

• Achieves successful delivery of clinical monitoring activities by meeting internal and external client requirements.
• Oversees the management of investigator sites to ensure compliance with the protocol, ICH-GCP and applicable regulations, and applicable SOPs.
• Contributes to Business Development activities participating in proposals and bid defenses as required.

 ACCOUNTABILITIES

1. Addresses and resolves all internal and external clinical issues for client research projects

• Creates and maintains clinical project documents, including Clinical Management Plans, Monitoring Guidelines, Site Operations Manuals and Monitoring Visit Letter templates, other activity templates, Monitoring visit presentations/scripts
• Serves as primary liaison for clinical monitoring issues, escalating as required
• Reviews and approves monitoring reports and ensures tracking of ongoing site issues
• Provides data as required for clinical operations performance metrics and project status metrics
• Liaises with CRA’s regarding site monitoring issues providing recommendations and suggestions for issue resolution
• Liaises with Clinical Operations Managers to resolve resource and performance issues