Manager, Clinical Trial Risk Analyst – Hyderabad, India
Department: Trial Delivery Support (TDS) / Trial Risk & Integrity Management (TRIM)
Company: Bristol Myers Squibb
Location: Hyderabad, Telangana, India
Job Type: Full-Time
About the Role
Bristol Myers Squibb is seeking a highly skilled Manager, Clinical Trial Risk Analyst to join the Trial Risk & Integrity Management (TRIM) organization. This role is a core contributor to the company’s Risk-Based Management (RBM) framework and plays a critical part in safeguarding patient safety, study integrity, regulatory compliance, and data reliability across global clinical trials.
The selected candidate will lead data-driven risk assessments, monitor study-level trends, identify emerging issues, and provide actionable insights to support decision-making across the clinical trial lifecycle. This position partners closely with Clinical Trial Risk Leads, Global Development Operations, Therapeutic Areas, Data Management, and Quality functions.
This is an opportunity to contribute to complex, high-impact clinical research efforts within a global biopharmaceutical leader.
Key Responsibilities
Support protocol de-risking by identifying critical-to-quality factors, essential data elements, and high-risk processes.
Collaborate with cross-functional leaders including Data Management, Biostatistics, Clinical Operations, Quality, and Medical teams to develop Key Risk Indicators (KRIs), Quality Tolerance Limits (QTLs), and Data Quality Assessment (DQA) specifications.
Lead the design and implementation of risk monitoring analytics and study-level data review strategies.
Conduct continuous risk surveillance, generate comprehensive risk reports, and escalate critical issues to the Clinical Trial Risk Lead and governance bodies.
Triages and reviews new and ongoing risk signals to support effective prioritization ahead of Risk Review Meetings (RRM).
Interpret clinical and operational data to reveal risk patterns, trends, outliers, and anomalies.
Drive risk discussions throughout the trial lifecycle and ensure risk management plans remain accurate and up to date.
Support development of performance metrics evaluating the impact and effectiveness of risk monitoring strategies.
Contribute to departmental process improvements, innovation initiatives, and RBM capability building.
Ensure oversight and quality management of external partners (Functional Service Providers, CROs, technology vendors).
Perform additional responsibilities as required by team leadership.
Required Qualifications & Experience
Bachelor’s degree in Life Sciences (preferred), Data Science, Analytics, Statistics, or related field.
Minimum 3 years of experience in the pharmaceutical industry, including 3 years of hands-on involvement in clinical trial operations or GCP-regulated activities.
Strong expertise in Risk-Based Monitoring principles such as Quality by Design, risk assessment, and centralized monitoring methodologies.
Ability to interpret and analyze complex clinical and operational datasets and convert insights into actionable risk signals.
Experience with analytics tools, risk assessment systems, and data visualization platforms.
Strong understanding of GCP, regulatory expectations, audits, health authority inspections, and CAPA processes.
Demonstrated ability to influence cross-functional teams and drive collaborative risk decisions.
Strong communication skills with the capability to present data-driven insights clearly and effectively.
Ability to align departmental priorities with organizational strategy and adapt to shifting business needs.
Preferred Skills
Experience working with RBM platforms, Veeva systems, and data analytics technologies.
Background in root cause analysis, quality risk management, or clinical quality oversight.
Ability to develop compelling data narratives to support risk assessment outcomes.
Why Join Bristol Myers Squibb
At Bristol Myers Squibb, employees contribute to life-changing work that advances scientific innovation and improves patient outcomes. The organization promotes flexibility, professional growth, and a collaborative culture shaped by integrity, passion, accountability, inclusion, and innovation.
Work Model
This role aligns with BMS’s occupancy structure. Specific on-site expectations will adhere to site-by-design or hybrid requirements based on business needs.
Equal Opportunity Commitment
BMS provides equal employment opportunities and supports applicants requiring workplace accommodations during the recruitment process.
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