Novartis is a global healthcare leader committed to improving patient lives through innovative medicines and cutting-edge research. With a strong presence in over 150 countries, Novartis fosters a collaborative and inclusive work environment where employees can thrive professionally and personally.
At Novartis, we believe in reimagining medicine to address some of the world’s most complex health challenges. Our Biomedical Research division focuses on groundbreaking discoveries, and we are looking for a Clinical Project Associate to join our team in Hyderabad.
Job Description
Key Responsibilities:
As a Clinical Project Associate, you will support the Study Lead in ensuring all trial deliverables are met within timelines, budget, and quality standards. Your role will include:
✔ Study Documentation & Compliance
- Assist in developing study documents, tools, and training materials.
- Maintain Trial Master Files (TMF) and ensure proper documentation.
- Support Clinical Study Reports (CSR) appendices preparation.
✔ Trial Management & Coordination
- Track patient enrollment, drug shipments, and batch numbers.
- Manage ECG machines and clinical trial material logistics.
- Assist in vendor and site coordination for sample tracking (PK/biomarker).
✔ Financial & Operational Support
- Assist in budget forecasting and financial tracking.
- Schedule meetings, prepare agendas, and distribute minutes.
- Support issue resolution plans and compliance checks.
✔ Cross-functional Collaboration
- Work closely with Global Clinical Supply, Novartis country teams, and vendors.
- Support Translational Clinical Biomarker and Compliance teams as needed.
Educational Qualifications
✔ Bachelor’s or Master’s degree in:
- Life Sciences (Biotechnology, Microbiology, Biochemistry, etc.)
- Pharmacy (B.Pharm, M.Pharm)
- Medicine BDS, Nursing
- Clinical Research (Diploma or Degree in Clinical Research)
Preferred Experience & Skills (Not Mandatory)
✔ 1-3 years of experience in:
- Clinical trial operations (Pharma/CRO/Healthcare)
- Regulatory documentation & TMF (Trial Master File) management
- Drug supply & logistics tracking
- Vendor/site coordination in clinical studies
✔ Technical & Soft Skills:
- Knowledge of ICH-GCP guidelines
- Proficiency in Microsoft Office & clinical trial software
- Strong organizational & communication skills
- Ability to work in a cross-functional team
Why Join Novartis?
✅ Innovative Science & Impactful Work – Contribute to life-changing medical research.
✅ Inclusive & Supportive Culture – Be part of a diverse, collaborative team.
✅ Career Growth & Learning – Access to professional development opportunities.
✅ Competitive Benefits – Health, wellness, and financial rewards.
📢 “At Novartis, we combine breakthrough science with a passion for patient care. Join us in shaping the future of medicine!”
