Job Description

Summary

#LI-Hybrid

Location: Singapore




About the Role:



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.

About the Role

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

Commitment to Diversity and Inclusion / EEO paragraph:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams


representative of the patients and communities we serve.

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

Join our Novartis Network:

Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Benefits and Rewards:

Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards



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

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.