Contracts Specialist

9 hours ago

Mumbai, Maharashtra, India IQVIA Full time ₹ 9,00,000 - ₹ 12,00,000 per year

Role & responsibilities :

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 innovative and efficient processes which are aligned with Novartis strategy

Activities & Interfaces:

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

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