● 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
● Tracks and oversees contract status including the dispatch and return of
contracts
● Negotiates financial & legal conditions, escalates issues as applicable
● Single point of contact for local Legal and ERC (e.g., for patient
reimbursement topics)
● Develops and standardizes local contract templates (e.g., for EC submission
if required by local regulation) and MSAs
● Adheres to financial standards, prevailing legislation, ICH/GCP, IRB/IEC,
Health Authority and SOP requirements
● Implements innovative and efficient processes which are aligned with strategy