Job Description

The Clinical Trial Associate (CTA) supports SSO Study Start-Up Manager, Study Start-up CRA and Clinical Research Associate in assigned studies during set-up and whole study lifecycle in compliance with Novartis processes, GCP/ICH and regulatory requirements.

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

Skills Desired

Clinical Research, Clinical Trials, Lifesciences (Inactive), Partner Relationship Management (PRM), Project Planning, Waterfall Model