Clinical Trial Associate

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.

Read our handbook (PDF 30 MB)

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