Are you passionate about clinical research and drug development? Novartis, one of the worldโs most trusted pharmaceutical companies, is hiring a Clinical Trial Associate at its Mumbai Head Office. This full-time position offers the opportunity to support clinical operations, regulatory compliance, and site management while contributing to innovative therapies that improve and extend patientsโ lives.
If you have experience in clinical trial management, IRB/EC submissions, and GCP/ICH guidelines, this role is an excellent career opportunity in the pharmaceutical industry.
Key Responsibilities
As a Clinical Trial Associate at Novartis, you will:
- Support document collection, preparation, and submission to IRB/EC and health authorities.
- Manage Investigator File (IF) and Trial Master File (TMF) setup and oversight.
- Coordinate vendor selection, TPRM process, and SIM entries.
- Ensure site โGreen Lightโ documentation completeness for drug release.
- Support preparation and translation of informed consent forms (ICFs) and patient-facing materials.
- Upload trial-related documents into CREDI/SUBWAY and archive paper TMFs.
- Collaborate with SSU team leads and managers to ensure trial setup timelines.
- Provide logistical support to CRA, CPM, and SSU Managers across trial phases.
- Maintain compliance with ICH/GCP, FDA, EMA, and local regulatory requirements.
Role Requirements & Qualifications
- Bachelorโs degree in Life Sciences, Pharmacy, Medical Administration, or related field.
- 1+ yearsโ experience in clinical operations or trial setup.
- Strong knowledge of drug development, ICH/GCP guidelines, and regulatory submissions.
- Proficiency in MS Excel, Word, PowerPoint; knowledge of SAP preferred.
- Ability to prioritize tasks, work independently, and collaborate effectively.
- Excellent communication and organizational skills.
Why Join Novartis?
At Novartis, you will be part of a mission-driven company dedicated to reimagining medicine and improving patient outcomes.
Benefits include:
- Competitive compensation package.
- Opportunities for career growth in global clinical operations.
- Access to Novartis Life Handbook for comprehensive rewards and benefits.
- Inclusive, diverse, and supportive work culture.
- Reasonable accommodations for individuals with disabilities.
Application Process
