Biocon Biologics is hiring a Clinical Project Assistant in Bengaluru, Karnataka, offering an excellent opportunity for candidates looking to build a career in clinical research, TMF management, and clinical operations.
This role is ideal for B.Pharm, M.Pharm, Pharm.D, Life Sciences graduates who want hands-on exposure to clinical trial documentation, eTMF systems, and study coordination activities.
With increasing demand for clinical operations professionals, this opportunity provides strong exposure to ICH-GCP compliant trial processes, making it a high-growth entry point into the CRO/pharma industry.
Key Responsibilities – Clinical Project Assistant
- Provide administrative and operational support to Clinical Operations teams
- Assist Clinical Project Managers (CPMs) and Therapeutic Area Heads
- Support clinical trial activities from start-up to close-out
- Maintain and manage Trial Master File (TMF/eTMF) ensuring audit readiness
- Track, review, and file essential clinical documents
- Coordinate with teams for EDC, eTMF access and system setup
- Generate and format study reports, dashboards, and tracking sheets
- Prepare meeting agendas, minutes, and presentations
- Support clinical study team (CST) in documentation and compliance
- Maintain training logs and study team lists
- Assist in budget tracking and invoice review for vendors
- Ensure compliance with ICH-GCP and regulatory guidelines
Required Qualifications
- Bachelor’s or Master’s degree in:
- B.Pharm / M.Pharm / Pharm.D
- BSc / MSc Life Sciences
- Basic understanding of:
- Clinical trials & study lifecycle
- TMF/eTMF systems
- ICH-GCP guidelines
- Strong skills in:
- Documentation & attention to detail
- Communication and coordination
- MS Excel, PowerPoint, reporting
Preferred Skills (High Impact for Selection)
- Knowledge of eTMF systems (Veeva Vault preferred)
- Exposure to clinical documentation review & audit readiness
- Understanding of ALCOA+ principles in clinical documentation
- Experience or internship in clinical research / hospital / CRO
Salary & Benefits
- 💰 Estimated Salary: ₹3.5 LPA – ₹6 LPA (based on market standards)
- 📍 Location: Bengaluru (On-site)
- 📈 Strong career growth in Clinical Operations / CRA / TMF Specialist roles
- 🌍 Exposure to global clinical trials and regulatory frameworks
Why This Role is Important for Freshers
This Clinical Project Assistant role acts as a gateway into Clinical Research industry, especially for candidates targeting:
- Clinical Trial Associate (CTA)
- Clinical Research Associate (CRA)
- TMF Specialist / Study Coordinator
- Clinical Data Management roles
You will gain real exposure to study lifecycle, documentation, and compliance, which are critical for CRO careers.
How to Apply
