Central Monitoring Operations Manager - FSP
RemoteFull-time8–14 yrsPosted 1 week ago
Leadership pharma role at Thermo Fisher Scientific. Needs 8+ years and a B.Sc. Remote.
About the role
Acts as a Subject Matter Expert (SME) and interdepartmental and client liaison for data analytics activities. Focuses on developing tools and processes to detect, investigate, diagnose, and mitigate clinical trial issues and risks. Leads one or more projects, including setting up functional plans, monitoring tools, and data review cycles.
What you'll do
- Ensure effective sponsor oversight, trend analysis, and signal detection to support trial quality and delivery
- Provide site monitoring expertise to the trial team and lead the implementation of monitoring and oversight approaches
- Oversee planning, execution, and issue management of site monitoring activities across all R/OPUs
- Ensure compliance with protocols, ICH-GCP, regulatory requirements , and maintain inspection readiness
- Lead centralized monitoring activities, including the development of study-specific tools, monitoring plans, and data review processes
What you need
- Clinical research
- Root cause analysis
- Site execution
- SOP writing
- Documentation
- PowerPoint