Clinical Trial Associate
Development
Summary
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.
About the Role
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
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Vacancy posted 20 days ago
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