The global CRO Precision Medicine Group is actively hiring for two high-demand clinical research roles in Bangalore: Documents Specialist II and Clinical Systems Administrator II.
These roles are ideal for professionals with experience in TMF/eTMF, CTMS, EDC, and clinical trial systems, offering exposure to oncology trials, biomarker-driven studies, and precision medicine programs.
With increasing demand for clinical data quality, regulatory compliance, and system integration, these positions provide strong career growth in clinical operations and clinical technology domains.
๐ Job Role 1: Documents Specialist II (TMF/eTMF)
๐ Location:
Bangalore, Karnataka, India
๐ Key Responsibilities (TMF Specialist)
- Perform document QC and indexing in eTMF systems
- Develop and maintain Trial Master File (TMF) plans
- Ensure compliance with ICH-GCP E6 Guidelines and regulatory frameworks
- Track TMF metrics and resolve document discrepancies
- Manage TMF close-out activities and final document submission timelines
- Coordinate eTMF export and ensure client handover with acknowledgment
- Prevent backlog through proactive document tracking and escalation
๐ Qualifications
- Bachelorโs degree in Life Sciences / Pharmacy / Healthcare / Business
- 5+ years clinical trial experience
- 3+ years TMF/eTMF experience
- Strong understanding of:
- 21 CFR Part 312 & 314
- EMA Clinical Trial regulations
- Proficiency in Microsoft Office tools
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๐ Job Role 2: Clinical Systems Administrator II
๐ Location:
Bangalore, Karnataka, India
๐ Key Responsibilities (Clinical Systems)
- Manage user access control for clinical systems (eTMF, CTMS, EDC, IRT)
- Configure and maintain systems like Veeva Vault and Medidata CTMS
- Handle site, study, and country setup within clinical systems
- Resolve system tickets and troubleshoot performance issues
- Support system integrations (EDC, CTMS, RTMS)
- Update system configurations (fields, picklists)
- Perform system archival and lifecycle management
๐ Qualifications
- Degree in Life Sciences / Pharmacy / IT / Healthcare
- 2+ years clinical trial experience
- 2+ years clinical systems experience
- Hands-on experience with:
- CTMS, EDC, eTMF, RTMS
- System configuration & integrations
- Strong communication and problem-solving skills
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๐ฏ Why Join Precision Medicine Group?
- Work on oncology & rare disease global trials
- Exposure to biomarker-driven precision medicine
- Opportunity to work with advanced clinical technologies (Veeva, Medidata)
- Strong CRO environment with global collaboration
- Career growth in clinical operations + clinical systems
๐ฉ How to Apply
Application Link For Documents Specialist II
Application Link For Clinical Systems Administrator II