Clinical Trial Associate

Key Responsibilities：

• Supports document collection, preparation, and adaption for submission to IRB/EC and Health Authorities as applicable; Sets-up systems
• Supports vendor selection, TPRM process, SIM entries
• 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); Supports preparation of patient facing material
• Responsible for completeness of uploaded trial related documents into CREDI/SUBWAY, 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:

• Commercial or medical training (e.g., vocational qualification, bachelor’s degree), Medical records administrator or equivalent education, preferably with experience in clinical operations
• Fluent in both written and spoken English, local language as needed
• Ideally several years of working experience with 1+ years´ of experience in clinical operations
• Understanding of clinical drug development with particular emphasis on trial set-up, and contracting
• Profound knowledge of MS Excel, MS Word, MS PowerPoint, ideally knowledge in SAP
• Strong process and system understanding

Desirable Requirements:

• 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
• Self-motivated, structured and committed way of working; Ability to prioritize and high coordination skills; Demonstrated collaboration and communication skills

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: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally:  https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf

Accessibility and Accommodation:

Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to diversityandincl.china@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

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. You can follow us via Novartis Recruitment WeChat Official Account and Novartis Recruitment WeChat Video Account