Contracts Specialist

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 :

Skills Required

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