Job Title
Manager, Clinical Trial Risk Analyst
Location
Hyderabad, Telangana, India
Department / Functional Area
Trial Delivery Support (TDS) / Trial Risk & Integrity Management (TRIM)
Position Summary
The Manager, Clinical Trial Risk Analyst (Mgr CTRA) is a key member of the TRIM organization, responsible for ensuring high-quality risk oversight across assigned BMS clinical trials. The role supports Risk-Based Management (RBM) through remote risk assessment, data quality analytics, trend detection, and study-level risk reporting. The Mgr CTRA partners closely with Clinical Trial Risk Leads (CTRLs), study teams, and cross-functional groups to detect emerging risks and maintain data integrity, patient safety, compliance, and operational excellence.
Key Duties & Responsibilities
1. Protocol & Study Risk Planning
Contribute to the Protocol De-risking process.
Identify critical data, critical processes, and success factors.
Collaborate with study team (DML, Statistician, GTL, Quality Lead, Clinical Scientist, Physician, etc.) to propose KRIs, QTLs, and data review strategies.
Define data source, data flow, review frequency, and external data transfer requirements.
2. Risk Monitoring & Analysis
Lead development of specifications for KRIs, Data Quality Assessments (DQA), and QTLs.
Perform regular study-level risk monitoring and provide holistic risk reports.
Escalate emerging risks (including QTL deviations) to the CTRL for governance review.
Triaging of new and open signals for Risk Review Meetings (RRM).
Participate in RRM discussions to validate, escalate, or close identified signals.
Provide insights connecting data findings to overarching risk management strategy.
3. Risk Management Lifecycle
Maintain and update Risk Management Plans throughout the trial lifecycle.
Support continuous improvement activities within TRIM and associated teams.
Contribute to development of risk monitoring performance metrics.
4. Cross-functional Collaboration
Partner with study teams to ensure aligned risk analytics and data review strategies.
Communicate findings to internal stakeholders to support decision-making.
Support RBM innovation, training, and implementation across the organization.
5. Vendor Oversight
Ensure effective oversight of CROs, technology partners, and FSPs performing risk management activities.
Monitor quality, compliance, and deliverables from external vendors.
6. Additional Responsibilities
Contribute to broader TRIM initiatives.
Perform duties assigned by TRIM leadership.
Reporting Structure
Reports to: Clinical Trial Risk Analyst Line Manager (TRIM organization)
Required Qualifications
Education
Bachelor’s degree required.
Preferred disciplines: Life Sciences, Analytics, Data Science, Statistics, Business, or related field.
Experience
Minimum 3 years in the pharmaceutical industry, with strong understanding of drug development.
Minimum 3 years of experience in clinical trial operations and/or Good Clinical Practice (GCP).
Experience with risk-based monitoring (RBM) principles:
Quality by Design
Risk Assessment & Control (RACT)
KRIs, QTLs
Risk analytics platforms (Veeva, etc.)
Technical Skills
Strong data analysis, data interpretation, and data visualization skills.
Ability to create compelling and actionable data insights.
Understanding of:
GCP and compliance expectations
Audits, health authority inspections (preferred)
Root cause analysis and CAPA (preferred)
Soft Skills
Strong leadership and stakeholder management.
Excellent communication, teamwork, and collaboration.
Ability to:
Influence cross-functional teams
Tell clear “data stories”
Align work with organizational strategy
Adapt quickly to changing priorities
About Life at BMS
Bristol Myers Squibb offers:
Meaningful, life-changing work across therapeutic areas.
Global teams with opportunities for innovation and growth.
Strong culture of flexibility, inclusion, integrity, and accountability.
Competitive benefits, career development programs, and incentives.
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