Supports country SSU strategy in close collaboration with the SSO Study Start-Up Team Lead and the SSO Study Start-Up Managers to ensure SSU timelines and deliverables are met according to country commitments
Job Summary
Supports country SSU strategy in close collaboration with the SSO Study Start-Up Team Lead and the SSO Study Start-Up Managers to ensure SSU timelines and deliverables are met according to country commitments.
Accountable for coordination, preparation, and execution of clinical study contracts and amendments (PI, site, institution, MSA, local vendors, etc., as applicable) for assigned projects.
Adheres to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirements.
Matching Summary
Supports country SSU strategy in close collaboration with the SSO Study Start-Up Team Lead and the SSO Study Start-Up Managers to ensure SSU timelines and deliverables are met according to country commitments.
Skills & Requirements
Must-have
clinical study contracts and amendments
negotiates financial & legal conditions
local Legal and ERC contact
adheres to financial standards
ICH/GCP, IRB/IEC, Health Authority and SOP requirements