Clinical Trial Associate

Summary

Internal Role Title: Clinical Trial Associate
Location: Singapore #LI-Hybrid

The Clinical Trial Associate (CTA) supports SSO Study Start-Up Manager and SSO Clinical Project Manager 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.
• Sets-up systems, supports vendor selection, documentation processes and data entry.
• Set-up and maintenance according to regulatory and Novartis requirements, document oversight and tracking, support 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. Supports preparation of patient facing material.
• Responsible for completeness of uploaded trial related documents. 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, health authority and 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

• Commercial or medical training (e.g., vocational qualification, bachelor’s degree), Medical records administrator or equivalent education, preferably with experience in clinical operations.
• At least 1 year of relevant working experience.
• Understanding of the international aspects of drug development process, including strong knowledge of international standards (GCP/ICH), health authorities (FDA/EMA), local/National Health Authorities regulations and Novartis standards.
• Strong process and system understanding. Self-motivated, structured and committed way of working.
• Ability to prioritize and high coordination skills. Demonstrated collaboration and communication skills.

Why Novartis?

Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us!

You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.

Commitment to Diversity & Inclusion: We are committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Company Details

Division: Development
Business Unit: Innovative Medicines
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