





Large pharmaceutical employer, mid-level experience requirement, and metro Hyderabad presence increases candidate competition.
Strong pharma and GCP-specific risk monitoring expertise limits transferability across industries.
Explicit 5-year pharma and 3-year clinical operations/GCP requirements plus domain-specific RBM and analytics expertise.
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Lead clinical trial risk oversight and remote risk assessment using statistical methodologies to identify emerging risks in clinical and operational data.
Develop, monitor, and report on Key Risk Indicators (KRIs), Data Quality Assessments (DQA), and Quality Tolerance Limits (QTLs) at the study level for compliance, patient safety, and data quality.
Evaluate, escalate, and report risks with potential systemic impact, supporting governance committees and partnering with cross-functional teams for risk management and continuous improvement.
Bachelor’s degree in Life Sciences (preferred), Analytics, Data Science, Statistics, Business, or related field.
Minimum 5 years pharmaceutical industry experience including at least 3 years in clinical trial operations and/or Good Clinical Practice.
Demonstrated expertise in Risk-Based Monitoring principles and relevant tools (e.g., RACT, risk analytics platforms, Veeva).
Work Experience Required: Minimum 5 years pharmaceutical industry experience. Notice Period: Not explicitly mentioned in the JD.
Experienced in clinical trial risk management with strong capability in data analysis and interpretation to translate data into actionable risk insights and ‘risk stories’.
Operates effectively in cross-functional environments influencing senior leadership and aligning risk management with organizational strategy.
Demonstrates advanced leadership in driving risk-based management innovation, education, and embedding within pharmaceutical clinical trial settings.