Advertisement
A leading clinical research organization is hiring a Clinical Business Analyst in Hyderabad, Telangana to support end-to-end clinical trial lifecycle activities. This role is ideal for professionals with strong experience in clinical operations, data management, safety, regulatory systems, and clinical IT platforms such as EDC, CTMS, eTMF, and safety databases.
If you are looking to grow your career in clinical R&D business analysis, this opportunity offers hands-on exposure to global studies, cross-functional collaboration, and regulated clinical environments.
🔍 Key Responsibilities – Clinical Business Analyst
- Lead business analysis activities across the full clinical trial lifecycle, including study start-up, data management, pharmacovigilance, and regulatory submissions
- Partner with Clinical Operations, Data Management, Medical Affairs, and Regulatory Affairs teams
- Act as a bridge between business and IT, translating clinical and scientific requirements into technical solutions
- Support implementation and optimization of EDC, CTMS, eTMF, RTSM/IWRS, and safety systems
- Drive adoption of clinical data standards such as CDISC (SDTM, ADaM, CDASH)
- Ensure compliance with ICH-GCP, FDA, EMA regulations
- Lead requirements gathering, gap analysis, UAT planning/execution, and post-implementation support
- Collaborate with CROs, vendors, and internal stakeholders for timely system delivery
- Apply Agile and SDLC methodologies to improve process efficiency and data quality
- Mentor junior business analysts and support cross-functional teams
🎓 Qualifications & Skills Required
- Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Clinical Research, Biotechnology, or related field
- Proven experience as a Clinical Business Analyst or similar role in clinical research
- Strong understanding of clinical trial operations and R&D systems
- Hands-on knowledge of EDC, CTMS, eTMF, Safety databases
- Experience with CDISC standards (SDTM, ADaM, CDASH)
- Familiarity with regulatory compliance (ICH-GCP, FDA, EMA)
- Experience in UAT, Agile, SDLC, and stakeholder management
- Excellent communication and documentation skills
💼 Benefits & Career Growth
- Work on global clinical trials and enterprise clinical systems
- Exposure to regulated clinical and pharmacovigilance environments
- Opportunity to collaborate with cross-functional and international teams
- Competitive salary and long-term career growth in clinical R&D and digital transformation
📝 How to Apply
Advertisement
Advertisement
