Job Title: Clinical Trial Associate (CTA)
Company: Novartis
Location: India
Job ID / Requisition: REQ-10061713
Date Posted: Sep 12, 2025
Employment Type: Full-time
Role Overview
The Clinical Trial Associate supports the planning, coordination, and oversight of clinical development projects. The role ensures compliance with protocols, regulatory requirements, and Novartis standards across all phases of clinical trials. Responsibilities include document management, trial setup, vendor coordination, and support for site activities.
Key Responsibilities
Support document collection, preparation, and adaptation for IRB/EC and Health Authority submissions.
Assist with vendor selection, TPRM process, and SIM entries.
Manage Investigator File (IF) and Trial Master File (TMF), ensuring completeness and regulatory compliance.
Ensure site “Green Light” completeness for initial and subsequent drug release in collaboration with local Qualified Person(s).
Support ICF preparation and translation into local languages; manage vendors if needed.
Ensure completeness and archiving of trial documents in CREDI/SUBWAY systems.
Support country Site Start-Up (SSU) strategy in collaboration with SSU Team Lead and Managers.
Ensure adherence to financial standards, legislation, ICH/GCP, IRB/IEC, Health Authority regulations, and SOPs.
Provide logistic support to SSU CRA, CRA, CPM, SSU Manager in all clinical trial phases.
Implement efficient and innovative processes aligned with Novartis strategy.
May travel to field sites to supervise or coordinate clinical studies.
May assist with clinical trial registration and disclosure postings.
Develop content for internal training materials and job aids.
Required Qualifications & Experience
Education: Vocational qualification or Bachelor’s degree in commercial or medical training, or equivalent (e.g., medical records administrator).
Experience: Several years in clinical operations with 1+ years of clinical operations experience preferred.
Knowledge of clinical drug development, trial setup, and contracting.
Strong understanding of GCP/ICH guidelines, FDA/EMA regulations, and local health authorities.
Proficient in MS Excel, Word, PowerPoint; SAP knowledge preferred.
Self-motivated, structured, and capable of prioritizing multiple tasks.
Strong collaboration and communication skills.
Skills & Competencies
Ability to coordinate multiple associates and investigators.
Effective document oversight and regulatory compliance.
High attention to detail and data integrity.
Problem-solving and process improvement mindset.
Strong organizational and time-management skills.
Company Highlights & Benefits
Purpose: Reimagine medicine to improve and extend people’s lives.
Culture: Inclusive, collaborative, and innovative.
Benefits: Detailed in Novartis Life Handbook – includes personal and professional development opportunities.
Diversity & Inclusion: Committed to a representative, inclusive work environment.
Accessibility: Reasonable accommodation provided for disabilities or medical conditions.
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Japan | Saitama |Tokyo :
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