Manager, Clinical Trial Risk Analyst

Biopharma Careers; Hyderabad; On-site; INR 1,500,000 - 2,100,000; Full time

Benefits offered by this job

Flexible work models

Disability accommodations

Job summary

Bristol Myers Squibb is seeking a Manager, Clinical Trial Risk Analyst to drive risk-based monitoring across trials, partner with study teams, and deliver comprehensive risk insights. The role emphasizes leadership, data-driven decision making, and ensuring compliance with GCP and QA standards.

The position offers opportunities for strategic impact within the TRIM organization and collaboration with CROs and technology providers.

Qualifications

• Bachelor-level degree in Life Sciences (preferred) or analytics-related field such as Data Science, Statistics, or Business.
• Minimum 3 years in the pharmaceutical industry with understanding of drug development and 3 years in clinical trial operations or Good Clinical Practice.
• Strong knowledge of Risk-Based Monitoring principles (Quality by Design, Risk Assessment & Control) and related tools (RACT, analytics platforms, Veeva, etc.).
• Technical expertise in data analysis and visualization to derive meaningful insights and tell a compelling data story.
• Ability to develop and implement visualizations and analyses to support Risk Management / Risk Monitoring needs.

Responsibilities

• Lead and collaborate in risk monitoring and KRIs/QTLs development for trials.
• Coordinate with Data Management Lead, Statistician, and study teams to propose KRIs and data flow.
• Produce regular holistic risk reports and escalate emerging risks to governance bodies.
• Support risk review discussions and maintain risk management plans.
• Contribute to continuous improvement initiatives within TRIM and broader organization.

Skills

GxP compliance

Risk-based monitoring

Data analysis

Communication

Leadership

Education

Bachelor's degree in Life Sciences or related field

Tools

RACT

Data analytics platforms

Veeva

Job description

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”, a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

Duties/Responsibilities

• Mgr CTRA to contribute to Protocol De-risking process, support identification of critical to success factors, critical to quality factors - including critical data, critical processes
• Collaborate with the Data Management Lead (DML), Statistician, Global Trial Lead (GTL), Quality Lead, Clinical Trial Physician, Clinical Scientist and other study team members to put together an initial proposal on KRIs (standard and study specific) and Quality Tolerance Limits (QTLs). Proposal to include information on critical data, data source, data flow, data review frequency, external data transfer frequency etc.
• Responsible to lead and collaborate with the study team in the development of specifications to set up the KRIs, Data Quality Assessments (DQA) and QTLs.
• Partners with the DML and other data review functions to determine the holistic data review strategy for the study and determines the function specific review objectives/analytics. Documents the Risk Monitoring data analysis responsibilities in the relevant functional plan.
• Responsible for regular risk monitoring at study level for and providing a holistic risk report at the agreed frequency. Ensure appropriate escalations of emerging risks (including QTL deviations) to the CTRL to be discussed at relevant governance bodies (e.g. Quality Council/Therapeutic Area leadership) and proactively shares knowledge and insights across the TRIM group.
• Triages new and previously open signals in preparation for the Risk Review Meetings (RRM) to prioritize the signals for discussion and prepare a list of recommended actions
• Contribute to the Risk Review discussion to determine if newly opened signals reveal potential risks and require follow-up investigation and if previously opened signals can be closed or need further investigation/monitoring/action. Relates the insights from the CM analysis back to the original risk discussions to share a compelling ‘risk story’.
• Drives or contributes to ongoing risk discussions within the study team throughout the lifecycle of the trial and ensures the risk management plan is updated and remains current
• Contribute to the development and maintenance of metrics that inform the evaluation of risk monitoring performance and effectiveness.
• Participation in initiatives / continuous improvement opportunities within the TRIM and broader organizations
• Supports the strategic direction of Risk Based Management within the business to include leadership of RBM innovation, education and embedding
• Ensure effective quality oversight and management of external partners (e.g. Function Service Providers, CROs, technology providers, etc.) performing Risk Management or Risk Monitoring activities on behalf of BMS
• Takes on additional responsibilities as directed by leadership
• Individuals printing or viewing a BMS controlled document from a source other than the Electronic Document Management System are responsible for ensuring that they are printing or viewing the current version.

Reporting Relationship

This role will report to a Clinical Trial Risk Analyst Line Manager within the TRIM organization.

Qualifications

• A minimum of a bachelor’s degree in one of the following disciplines or related field: Life Sciences (preferred); Analytics; Data Science; Statistics; Business
• At least 3 years in the pharmaceutical industry with sound understanding of drug development and 3 years of experience in clinical trial operations and/or Good Clinical Practice
• Robust understanding of Risk-Based Monitoring principles (Quality by Design, Risk Assessment & Control) and relevant tools (e.g. RACT, risk analytics platforms, Veeva and other quality systems)
• Technical expert in data analysis and interpretation using data visualizations to derive meaningful insights; and an ability to effectively tell the story of the data findings
• Ability to contribute to the development and implementation of data visualizations and analyses to support Risk Management / Risk Monitoring business needs.
• Robust understanding of GCP, compliance and regulatory expectations.
• Experience of audits and health authority inspections, root cause analysis and CAPA is desirable.
• Strong leadership skills with an ability to influence and manage key internal stakeholders
• Excellent communication, collaboration and teamwork skills with an ability to drive cross-functional stakeholders to consensus.
• An ability to create a compelling story based on data insights which is meaningful to the target audience.
• An ability to make the connection between organizational strategy and departmental objectives, and utilize this understanding to drive priorities
• Open mindset with an ability to be flexible, responsive, and proactive in addressing new challenges, opportunities, and demands.
• Ability to quickly adapt to changes while maintaining effectiveness and staying aligned with business goals
• Individuals printing or viewing a BMS controlled document from a source other than the Electronic Document Management System are responsible for ensuring that they are printing or viewing the current version.

How We Work

Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplaceaccommodations/adjustmentsand ongoing support in their roles. Applicants can request a reasonable workplaceaccommodations/adjustmentsprior to accepting a job offer. If you require reasonableaccommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [e-mail] . Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

For roles based in Los Angeles County only:

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

R1606176 : Manager, Clinical Trial Risk Analyst