Clinical Trial Associate

3 days ago


Singapore Novartis Singapore Full time

About The Role The Clinical Trial Associate (CTA) supports the SSO Study Start‐Up Manager and SSO Clinical Project Manager in assigned studies during set‐up and the entire study lifecycle in compliance with Novartis processes, GCP/ICH and regulatory requirements. Location: Singapore Key Responsibilities Supports document collection, preparation and adaptation for submission to IRB/EC and Health Authorities as applicable. Sets up systems, supports vendor selection, documentation processes and data entry. Maintains 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 and prepares patient‐facing material. Ensures completeness of uploaded trial‐related documents and supports the country SSU strategy in collaboration with the SSU Team Lead and SSU Managers to meet SSU timelines and deliverables. Provides logistic support to SSU CRA, CRA, CPM and SSU Manager in all phases of the clinical trial, implementing innovative and efficient processes aligned 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 drug development process, including strong knowledge of GCP/ICH, health authorities (FDA/EMA), local/National Health Authority regulations and Novartis standards. Strong process and system understanding; self‐motivated, structured and committed way of working. Ability to prioritize and coordinate at a high level; demonstrated collaboration and communication skills. Commitment to Diversity and Inclusion / EEO Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Benefits and Rewards Read our handbook to learn about all the ways we'll help you thrive personally and professionally: Apply To apply, visit Novartis Careers or sign up for our talent community to stay connected and learn about suitable career opportunities as they arise: #J-18808-Ljbffr



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