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.
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