The "gate-keeper" role of a global clinical submission project leader is to lead the team and manage the functions, the issues, the changes, the processes, the procedures, especially monitor and QC the data and the documentation. "On-time" timelines and targets will be achieved if the practice of leadership, management and communication are performed religiously, thoroughly, completely, logically, logistically and concisely. Find the weakest link, whatever and where ever and "support" the link.
Global Project Leadership and Management for Clinical Submission occurs across all sponsor functions and all vendors, all tasks, all deliverables, all responsibilities, all accountabilities, all teams, contributing to the filing and the eventual submission -
- Regulatory
- Clinical
- Nonclinical
- CMC
- Data Management
- Statistics
- Programming
- Project
- Publishing
- Quality Control
- Quality Assurance
- Contributing Functions
- Outsourced, Contractors, Consultants, Vendors
- All Data
- All Databases, study level and global integrated
- Experts, Advisory Committees, Opinion Leaders
- Adjudicators
- Timelines, Tracking, Milestones, Monitoring, Communication, FDA Correspondence
- Pharmacovigilence.
Did I miss anyone, any team, any task, any function?
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