Purpose: 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 Novartis processes, GCP/ICH, and regulatory requirements.

Accountabilities

- 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 creative and efficient processes which are aligned with Novartis strategy

Activities & Interfaces:

- Externally facing role with impact on Principal Investigators and Institution/Site business offices.

Skills: Clinical Study Contracting & Coordination, clinical trial agreements (CTAs), master service agreements (MSAs), Regulatory & Compliance Knowledge, SSO Contracting, SSU strategy

Experience: 1.00-5.00 Years

📌 Contracts Specialist (Mumbai)
🏢 Iqvia
📍 Mumbai