Contract Specialist
2 weeks ago
Years of Experience: 1-3 Years.
Job Location: Thane (Office based)
Educational qualification: Any Graduate with CRO experience background.
Job Overview:
The SSO Contracting Specialist is accountable for coordination, preparation, and execution of clinical study contracts (PI, site, institution, MSA, local vendors, etc., as applicable) in a direct country or extended country group (OPC and satellite countries) in close collaboration with SSO Study Start-Up Managers, SSO Clinical Project Managers and SSO Finance Specialists in compliance with the client processes, GCP/ICH, and regulatory requirements.
Responsibilities:
1. 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
2. Accountable for coordination, preparation, and execution of clinical study contracts and amendments (PI, site, institution, MSA, local vendors, etc., as applicable) for assigned projects
3. Tracks and oversees contract status including the dispatch and return of contracts
4. Negotiates financial & legal conditions, escalates issues as applicable
5. Single point of contact for local Legal and ERC (e.g., for patient reimbursement topics)
6. Develops and standardizes local contract templates (e.g., for EC submission if required by local regulation) and MSAs
7. Adheres to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirements
8. Implements innovative and efficient processes which are aligned with Client strategy
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