Are you ready to make a significant impact in the world of clinical trials? Novartis, a global leader in the pharmaceutical industry, is seeking a Clinical Trial Associate (CTA) to join their team in Mumbai, India. With over 100,000 patients participating in our clinical trials at any given time, this is your chance to be a part of a powerhouse of Global Clinical Operations. If you have a background in clinical operations and a passion for innovative medicine, this opportunity is for you.
Job Overview
Position: Clinical Trial Associate (CTA)
Location: Mumbai, India
Job ID: REQ-10015731
Job Purpose
As a Clinical Trial Associate (CTA) at Novartis, you will support the SSO Study Start-Up Manager and the SSO Clinical Project Manager in assigned studies throughout the study lifecycle. This role involves compliance with Novartis processes, GCP/ICH, and regulatory requirements.
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.
- 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.
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Novartis Hiring Clinical Trial Associate (CTA) – Mumbai, India[/caption]
Key Responsibilities
- 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.
Experience/Professional requirement:
- Ideally several years of working experience with 1+ year of experience in clinical operations
- Understanding of clinical drug development with particular emphasis on trial set-up and contracting Competencies:
- Profound knowledge of MS Excel, MS Word, MS PowerPoint, ideally knowledge in SAP
- 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
Skills & Knowledge:
- 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
Role Requirements
- Education: Commercial or medical training (e.g., vocational qualification, bachelor’s degree), preferably with experience in clinical operations.
- Language Proficiency: Fluent in both written and spoken English; local language proficiency as needed.
- Experience: Ideally several years of working experience with at least 1+ year of experience in clinical operations.
- Skills: Proficient in MS Excel, MS Word, MS PowerPoint, and preferably SAP. Strong understanding of the international aspects of drug development, GCP/ICH standards, and regulatory requirements.
- Attributes: Self-motivated, structured, and committed with excellent prioritization and coordination skills. Strong collaboration and communication abilities.
How to Apply
Interested candidates can apply online through the Novartis career portal:
Apply Here.
https://pharmastuff.org.in/job/novartis-hiring-clinical-trial-associate
