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 cutting-edge and productive processes which are aligned with Novartis strategy
Activities & Interfaces:
Externally facing role with impact on Principal Investigators and Institution/Site business offices.
📌 Contracts Specialist Mumbai
🏢 Iqvia
📍 Mumbai