Manager, Clinical Trial Risk Analyst – Hyderabad, Telangana, India
Company: Bristol Myers Squibb
Department: Trial Delivery Support (TDS) / Trial Risk & Integrity Management (TRIM)
Employment Type: Full-Time
About the Role
Bristol Myers Squibb is hiring a Manager, Clinical Trial Risk Analyst to support global clinical trial oversight within the Trial Risk & Integrity Management (TRIM) function. This role is central to the organization’s Risk-Based Management (RBM) framework and ensures that clinical trials are conducted with the highest standards of compliance, data quality, operational excellence, and patient safety.
The position involves advanced analytics, risk identification, and cross-functional collaboration to support study teams across the clinical research portfolio. The selected candidate will provide expert risk insights based on statistical evaluation of clinical and operational data, and will contribute directly to the governance and strategic planning of trial oversight.
Key Responsibilities
Support protocol de-risking by identifying critical-to-quality factors, essential study data, and high-risk operational processes.
Partner with Data Management, Biostatistics, Clinical Operations, Quality, and Medical teams to define Key Risk Indicators (KRIs), Quality Tolerance Limits (QTLs), and Data Quality Assessments (DQAs).
Lead the development of specifications for KRIs, QTLs, and risk analytics.
Define and document holistic data review strategies and cross-functional analytical objectives.
Conduct continuous risk monitoring at the study level and prepare periodic risk reports for governance bodies.
Escalate emerging risks, including QTL deviations, to the Clinical Trial Risk Lead (CTRL) for decision-making.
Review and prioritize signals before Risk Review Meetings (RRMs) and recommend corrective actions.
Drive ongoing risk discussions throughout the trial lifecycle and maintain updated risk management plans.
Provide data-driven insights that clearly communicate risk patterns, trends, and significant findings.
Contribute to the development of metrics assessing the performance and impact of risk monitoring activities.
Participate in TRIM-driven initiatives, continuous improvement programs, and RBM capability projects.
Oversee quality expectations of external partners, including CROs, functional service providers, and technology vendors.
Perform additional responsibilities as required by leadership.
Reporting Structure
This position reports directly to a Clinical Trial Risk Analyst Line Manager within the TRIM organization.
Required Qualifications and Experience
Bachelor’s degree in Life Sciences (preferred), Data Science, Analytics, Statistics, Business, or a related field.
Minimum 3 years of experience in the pharmaceutical industry, including 3 years in clinical trial operations or Good Clinical Practice (GCP) environments.
Strong working knowledge of Risk-Based Monitoring (RBM), Quality by Design, risk assessment tools, and centralized monitoring strategies.
Proficiency in analyzing clinical and operational datasets, generating visualizations, and interpreting statistical insights.
Practical experience with risk analytics platforms, RACT tools, Veeva systems, and clinical quality platforms.
Strong understanding of GCP, regulatory expectations, and processes related to audits, root cause analysis, and CAPA.
Proven leadership ability and stakeholder management skills across global functions.
Strong communication and presentation skills, with the ability to influence cross-functional decision-making.
Ability to develop compelling data narratives that clearly articulate findings and risk implications.
Adaptability in dynamic environments with a proactive, flexible approach to evolving business needs.
Ability to align team objectives with organizational strategy and drive prioritization efforts.
Preferred Experience
Involvement in clinical quality oversight, quality risk management, or RBM implementation projects.
Experience participating in health authority inspections or internal audits.
Exposure to technology-enabled risk monitoring solutions.
Why Join Bristol Myers Squibb
Bristol Myers Squibb offers a mission-driven work environment focused on advancing scientific breakthroughs and improving patient lives. Employees benefit from:
A collaborative and inclusive culture
Opportunities for career growth
Competitive benefits and flexible work arrangements
Access to global clinical research programs and multidisciplinary teams
Workplace Model
This role follows the BMS occupancy structure, which may include site-by-design or hybrid expectations based on business needs. On-site presence supports collaboration, innovation, and productivity.
Equal Opportunity Commitment
BMS is committed to creating an accessible workplace for individuals with disabilities and provides accommodations upon request. Applicants are encouraged to seek support during any stage of the recruitment process.
Important Candidate Information
The company will not request payments, financial information, or personal identification during the application process.
All applicant data will be processed according to applicable data protection regulations.
Qualified applicants with prior arrests or convictions will be considered in line with regional requirements.
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