Responsible for the quality deliverables at the country level, following project requirements and applicable country rules with moderate oversight
Job Summary
Responsible for the quality deliverables at the country level, following project requirements and applicable country rules with moderate oversight.
Monitors basic financial aspects of the project and ensures compliance with forecasted submission/approval timelines, investigating and escalating delays.
Supports continuous improvement of quality in all Site Start-Up (SSU) components at the country level.
Matching Summary
Responsible for the quality deliverables at the country level, following project requirements and applicable country rules with moderate oversight.
Skills & Requirements
Must-have
Quality deliverables at country level
Track milestone progress
Monitor financial aspects
Comply with SOPs and WIs
Submit to Trial Master File (TMF)
Prepare and submit regulatory applications
Nice-to-have
Support continuous improvement
Act as liaison and facilitator
Provide input in local SOPs
Support creation of internal training materials
Key Requirements
Bachelor’s Degree
Understanding of clinical trial process
Understanding of clinical trial start-up processes