Summary
At Novartis, over 100,000 patients are engaged in our clinical trials at any given time. Our Global Clinical Operations (GCO) team is designed to expedite trial recruitment and delivery, providing patients with timely access to innovative treatments. As a key link between science and medicine, you could significantly impact patient care.
About the Role
Job Purpose:
The Clinical Trial Associate (CTA) supports the SSO Study Start-Up Manager and SSO Clinical Project Manager throughout the study lifecycle, ensuring compliance with Novartis processes, GCP/ICH, and regulatory requirements. This role involves coordinating document collection, system setup, vendor selection, and ensuring the accuracy and completeness of trial documentation.
Key Responsibilities:
Document Management: Collect, prepare, and adapt documents for submission to IRB/EC and Health Authorities. Manage the Investigator File (IF) and Trial Master File (TMF), ensuring compliance with regulatory and Novartis standards.
Site Support and Coordination: Provide logistic support for site setup and trial initiation, including vendor setup and management. Ensure all necessary documentation is in place for drug release and site "Green Light" readiness.
Translation and Material Preparation: Assist in translating informed consent forms and preparing patient-facing materials, managing vendors as necessary.
Strategic Collaboration: Work closely with the SSU Team Lead and SSU Managers to meet timelines and deliverables, ensuring adherence to financial standards and regulatory requirements.
Process and System Management: Utilize systems like CREDI/SUBWAY for document management and archiving. Maintain strong knowledge of MS Excel, Word, PowerPoint, and SAP.
Role Requirements:
Skills & Knowledge:
Why Novartis:
Our mission is to reimagine medicine to improve and extend lives, aiming to be the most valued and trusted medicines company globally. Achieving this vision is possible with our dedicated and passionate associates. Join us in creating a brighter future by exploring more about our mission and culture.
Commitment to Diversity & Inclusion:
Novartis is committed to building a diverse and inclusive workplace that reflects the patients and communities we serve.
Benefits and Rewards:
For detailed information about our benefits and rewards, refer to the Novartis Life Handbook.
Join our Novartis Network:
If this role doesn't align with your career goals, join our Novartis Network to stay informed about future opportunities.
Location: Mumbai, India
Division: Development
Business Unit: Innovative Medicines
Company / Legal Entity: Novartis Healthcare Private Limited
Functional Area: Research & Development
Job Type: Full-time, Regular
Shift Work: No
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