Manager, Clinical Trial Risk Analyst

Bristol Myers Squibb; Hyderabad; On-site; INR 1,200,000 - 1,700,000; Full time

Job summary

Bristol Myers Squibb in Hyderabad, India, seeks a Clinical Trial Risk Analyst to drive risk monitoring across studies. You will collaborate with the Data Management Lead, statisticians, and QA leaders to define KRIs and QTLs, outline data sources and review frequencies, and set up data quality assessments.

Lead risk reviews, triage signals, and prepare holistic risk reports for governance. Strong background in Life Sciences and 3+ years in pharma with GCP knowledge required.

Qualifications

• Bachelor's degree in Life Sciences or related field required.
• 3+ years in pharma with clinical trial operations and GCP knowledge.
• Strong knowledge of Risk-Based Monitoring principles and tools.

Responsibilities

• Contribute to KRIs, DQA, and QTL setup with the study team.
• Lead risk monitoring at the study level and provide holistic reports.
• Escalate emerging risks to governance bodies and share insights.
• Develop metrics to evaluate risk monitoring performance.
• Collaborate across data management, analytics and trial teams.

Skills

Risk-Based Monitoring

Data visualization

GCP knowledge

Leadership

Communication

Stakeholder management

Education

Bachelor's degree in Life Sciences

Tools

RACT

Veeva

Job description

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

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 Life Sciences (preferred); Analytics; Data Science; Statistics; Business; is required.
• 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 is required.
• 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.