Clinical Trial Associate
Skills
About the role
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
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
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Division
Development
Business Unit
Development
Location
Singapore
Site
Mapletree Business City (MBC)
Company / Legal Entity
SG04 (FCRS = SG004) Novartis Singapore Pte Ltd
Functional Area
Research & Development
Job Type
Full time
Employment Type
Regular
Shift Work
No
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