Key Responsibilities

• Supports document collection, preparation, and adaption for submission to IRB/EC and Health Authorities as applicable
• IF and TMF management (country and site TMF); set-up and maintenance according to regulatory and Novartis requirements; document oversight and tracking
• Supports Vendor set-up as applicable
• Checks site “Green Light” completeness and ensures all documentation is in place for initial and subsequent drug release in collaboration with the local Qualified Person(s)
• Supports preparation and translation of ICF into local languages (including vendor management if necessary)
• Responsible for completeness of uploaded trial related documents into Trial Master File, including archiving of paper TMFs
• Supports country SSU strategy in close collaboration with SSU Team Lead and SSU Managers to ensure SSU timelines and deliverables are met according to country commitments
• Ensures adherence to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirements
• Provides logistic support to SSU CRA, CRA, CPM, SSU Manager in all phases of the clinical trial
• Implements innovative and efficient processes which are in line with Novartis strategy

      Essential Requirements:

• Degree or equivalent in a scientific, medical, or related field, with prior exposure to clinical operations (preferably ≥1 year).
• Basic knowledge of clinical drug development, particularly study start-up, submissions, and contracting workflows.
• Demonstrates understanding of ICH/GCP, IRB/IEC, and Health Authority requirements, ensuring compliance in daily activities.
• Supports preparation, collection, tracking, and maintenance of regulatory documents and TMF to ensure completeness and audit readiness.
• Able to support IRB/EC and Health Authority submissions, including document preparation and adaptation.
• Proficient in maintaining study systems (e.g., document repositories, tracking systems) and ensuring timely and complete uploads