摘要
Location: Singapore #LI-Hybrid
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
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! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
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.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
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
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
