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Manager, Clinical Trial Risk Analyst

3 years
Not Disclosed
10 Nov. 14, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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.