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Sr. Manager, Clinical Trial Risk Analyst

6 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

Senior Manager, Clinical Trial Risk Analyst Line Manager (Sr. Mgr CTRAM)

Department / Functional Area

Trial Delivery Support (TDS) / Trial Risk & Integrity Management (TRIM)


Position Summary

The Senior Manager, Clinical Trial Risk Analyst Line Manager (Sr. Mgr CTRAM) is a key member of the Clinical Trial Risk Management team under TRIM.
This role supports the Risk-Based Management (RBM) framework by evaluating, monitoring, and reporting risks across assigned clinical trial portfolios.
The incumbent analyzes study-level data using advanced analytics to identify trends, outliers, deviations, and potential risks affecting patient safety, data quality, compliance, and operational performance.

The role partners closely with:

  • Clinical Trial Risk Lead (CTRL)

  • R&D Quality (Risk Governance & Operations)

  • Global Development Operations (GDO)

  • Therapeutic Area (TA) functions


Key Duties & Responsibilities

1. Team Leadership & People Management

  • Lead and oversee a team of risk monitoring professionals.

  • Assign resources, balance workload, forecast future needs.

  • Provide coaching, mentoring, feedback, and career development.

  • Foster a culture of accountability, diversity of thought, and integrity.

  • Support engagement, retention, and performance excellence.

2. Risk Management & Oversight

  • Lead Protocol De-risking and identify critical-to-quality factors (critical data & processes).

  • Collaborate with statistical, clinical, and data management teams to propose KRIs, QTLs, and DQAs.

  • Develop specifications for KRIs, data quality assessments, and QTLs.

  • Conduct holistic risk monitoring, generate study-level risk reports, and escalate emerging risks.

  • Prepare for and participate in Risk Review Meetings (RRM).

  • Provide insights linking risk data to the broader “risk story.”

  • Maintain and update study risk management plans throughout the lifecycle.

3. Data Analysis & Reporting

  • Perform remote assessment of clinical and operational data to detect trends, outliers, and anomalous signals.

  • Use data visualizations and analytics to generate meaningful insights.

  • Contribute to development of visualizations supporting risk monitoring operations.

  • Support metrics development to evaluate risk monitoring effectiveness.

4. Cross-Functional Collaboration

  • Partner with CTRL, DML, Statistician, Clinical Scientist, Quality Lead, and other stakeholders.

  • Support oversight of CROs, FSPs, and technology vendors conducting risk monitoring activities.

  • Participate in governance discussions (Quality Council, TA leadership).

  • Lead or contribute to continuous improvement and RBM innovation initiatives.

5. Study & Organizational Support

  • Support internal decision making and regulatory submissions by delivering high-quality risk evaluations.

  • Ensure timely triage and preparation of signals for RRM discussions.

  • Guide new team members through training, onboarding, and mentorship.

  • Take on additional responsibilities as assigned by leadership.


Reporting Relationship

Reports to a member of the Clinical Trial Risk Management Leadership Team within the TRIM organization.


Qualifications

Education

  • Bachelor’s degree in Life Sciences (preferred), Analytics, Data Science, Statistics, Business, or equivalent.

Experience

  • Minimum 5 years in the pharmaceutical industry with strong understanding of drug development.

  • At least 3 years in clinical trial operations and/or GCP-related work.

  • Demonstrated expertise in Risk-Based Monitoring (Quality by Design, Risk Assessment & Control).

  • Experience with risk analytics platforms, RACT tools, Veeva, and quality systems.

  • Exposure to audits, inspections, root cause analysis, and CAPA (preferred).

  • Proven people leadership experience.

Technical Skills

  • Strong data analysis and interpretation skills using visual analytics.

  • Ability to create data visualizations and communicate insights effectively.

  • Deep understanding of GCP and regulatory expectations.

Leadership & Soft Skills

  • Excellent communication, collaboration, and influence skills.

  • Ability to drive cross-functional alignment and consensus.

  • Strategic thinker able to connect organizational goals to departmental priorities.

  • Flexible, proactive, open mindset to adapt to change.

  • Ability to articulate long-term benefits of change and drive stakeholder alignment.


Work Environment & Flexibility

BMS supports flexible work models under the company’s On-site Protocol, which determines on-site, hybrid, field-based, or remote arrangements depending on role responsibilities.