AstraZeneca is inviting applications for the position of Senior Specialist, Risk Based Quality Management (RbQM) in Bangalore, India. This opportunity is ideal for professionals with experience in clinical research, centralized monitoring, Risk-Based Monitoring (RBM), and Risk-Based Quality Management (RbQM) who are passionate about improving clinical trial quality and protecting patient safety.
The Senior Specialist, Risk Based Quality Management role offers the opportunity to collaborate with global clinical teams, analyze clinical data trends, identify quality risks, and contribute to innovative clinical development programs using AI, analytics, and centralized monitoring methodologies.
If you are looking for AstraZeneca Clinical Research Jobs, Risk Based Quality Management Jobs in Bangalore, or Clinical Operations Jobs in India, this opportunity offers an excellent career path within one of the world’s leading pharmaceutical companies.
Key Responsibilities
The selected candidate will:
- Lead centralized monitoring (CM) activities for assigned clinical studies.
- Ensure compliance with ICH-GCP R2 guidelines and AstraZeneca’s RbQM framework.
- Collaborate with global and local study teams throughout study execution.
- Monitor Critical-to-Quality (CtQ) factors across clinical trials.
- Review clinical data trends to identify potential quality risks and operational issues.
- Conduct CtQ review meetings and present risk insights to stakeholders.
- Support Study Quality Risk Management Plans (SQRMP).
- Improve centralized monitoring processes and drive operational excellence.
- Act as an RbQM subject matter expert across cross-functional teams.
- Deliver high-quality project milestones within agreed timelines.
Required Qualifications
Applicants should possess:
- Bachelor’s degree in Life Sciences or a related discipline.
- Minimum 2 years of experience in Pharmaceutical, Biotechnology, or CRO industry.
- Knowledge of clinical research and drug development processes.
- Understanding of:
- Risk-Based Monitoring (RBM)
- Risk-Based Quality Management (RbQM)
- Centralized Monitoring
- Strong analytical and data interpretation skills.
- Working knowledge of ICH-GCP guidelines.
- Project management and risk management capabilities.
- Excellent English communication skills.
- Ability to work effectively in global cross-functional teams.
Preferred Qualifications
Candidates with the following experience will have an advantage:
- Previous experience in Centralized Monitoring or RbQM roles.
- Experience coordinating cross-functional teams.
- Stakeholder management experience.
- Ability to contribute to complex global clinical projects.
Why Join AstraZeneca?
Working at AstraZeneca offers:
- Global clinical research exposure
- Hybrid working opportunities
- AI-powered clinical development environment
- Career growth in Clinical Operations
- Continuous learning and mentorship
- Inclusive and diverse workplace
- Opportunity to improve patient safety through innovative monitoring strategies
- Collaboration with global clinical experts
Estimated Salary
Based on current market trends for similar positions in Bangalore:
Estimated Annual CTC: โน14 LPA โ โน22 LPA
Actual compensation may vary depending on experience, skills, internal pay structure, and interview performance.
How to Apply
