PHARMAFull-time
Manager, Clinical Trial Risk Analyst
By Admin · Clinical Research & Clinical Operations
HYDERABAD (IN)ONSITEPOSTED: 9/11/2026
PHARMAFull-time
HIRING ORGANIZATIONBRISTOL MYERS SQUIBBPharmaceuticals
BR
ROLE OVERVIEW
Lead clinical trial risk monitoring and risk-based management activities by translating clinical data into actionable risk insights. Partner with cross-functional study teams to identify critical risks, establish KRIs and QTLs, monitor signals, and support data-driven trial oversight.
ROLE DEFINITION & RESPONSIBILITIES
- •Contribute to protocol de-risking and identify critical-to-success and critical-to-quality factors
- •Collaborate with study teams to define KRIs, QTLs, DQAs, critical data, data sources and review strategies
- •Lead development and maintenance of specifications for KRIs, DQAs and QTLs
- •Perform regular study-level risk monitoring and provide holistic risk reports with appropriate escalation of emerging risks
- •Triage new and existing risk signals for Risk Review Meetings and recommend follow-up actions
- •Interpret clinical monitoring data and communicate compelling risk stories to support investigation, monitoring and risk decisions
- •Drive ongoing risk-management discussions and keep study risk-management plans current
- •Support risk-monitoring metrics, continuous improvement, RBM innovation and oversight of external risk-management partners
Reporting Hierarchy: Reports to a Clinical Trial Risk Analyst Line Manager within the TRIM organization; collaborates closely with Data Management, Statistics, Global Trial Leadership, Quality, Clinical Operations, Clinical Science and external partners
* Role responsibilities and qualifications synthesized based on industry benchmark standards.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Bachelor's degree in Life Sciences, Analytics, Data Science, Statistics, Business or related field
- At least 3 years of pharmaceutical industry experience with sound understanding of drug development
- At least 3 years of experience in clinical trial operations and/or Good Clinical Practice
- Strong understanding of Risk-Based Monitoring principles including Quality by Design, risk assessment and risk control
- Technical expertise in data analysis, interpretation and data visualization
- Strong understanding of GCP, compliance and regulatory expectations
PREFERRED QUALIFICATIONS
- •Experience with audits and health authority inspections
- •Root cause analysis and CAPA experience
- •Experience with RACT, risk analytics platforms, Veeva and quality systems
- •Experience leading RBM innovation, education or organizational change initiatives
REQUIRED VERIFIED SKILLS
Clinical trial risk management
Risk-Based Monitoring
Quality by Design
risk assessment
risk control
KRI
QTL
Data Quality Assessment
clinical data analysis
data visualization
GCP
clinical trial operations
drug development
regulatory compliance
risk signal triage
risk reporting
Veeva
RACT
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Comprehensive benefits, wellbeing support, flexible work options, inclusion initiatives, professional development and career growth opportunities
No salary range, fixed compensation amount or bonus/equity figure is disclosed in the supplied posting. Compensation should therefore be evaluated using the employer's applicable local total-rewards package rather than an assumed numeric benchmark.
ORGANIZATION CONTEXT & CULTURE
Bristol Myers Squibb is a global biopharmaceutical company focused on discovering, developing and delivering innovative medicines for serious diseases. Its work combines scientific innovation with a strong patient-focused mission.
TEAM SIZE: 30,000+ employees
INDUSTRY: Pharmaceuticals
Culture: Purpose-driven and patient-focused culture emphasizing collaboration, accountability, urgency, inclusion, wellbeing, innovation and continuous learning.
EXPECTED CAREER ROADMAP
Potential progression includes Senior Clinical Trial Risk Analyst or Risk Management Lead roles, followed by broader Trial Risk Management leadership, clinical operations risk leadership or strategic RBM program management opportunities.
APPLICATION ADVISORY
Emphasize pharmaceutical and clinical trial experience, especially Risk-Based Monitoring, GCP, Quality by Design, KRIs and QTLs; demonstrate examples of using data analysis or visualization to identify and communicate clinical risks; highlight experience working with cross-functional study teams and reaching stakeholder consensus; mention Veeva, RACT, risk analytics platforms, audits, inspections, RCA or CAPA where applicable; demonstrate strong data storytelling and the ability to translate findings into clear risk actions.
RECOMMENDED TRAINING
1/5
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