Senior Manager I, Clinical Trial Risk Analyst

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.

Job Description

QMS-TMP-12-1A-4-2

Section 1: Job Details

Job Title/Role Senior Manager I, Clinical Trial Risk Analyst

Department

Name/Functional Area

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

Location

Section 2: Job Description

Position Summary The Senior Manager I, Clinical Trial Risk Analyst (Sr. Mgr I CTRA), is a member

of the Clinical Trial Risk Management team under Trial Risk & Integrity

Management (TRIM).

The Clinical Trial Risk Management capability is a critical element of the Risk

Based Management (RBM) framework.

Each Sr. Mgr I CTRA will be assigned a certain part of the Bristol-Myers Squibb

clinical trial portfolio and will work conjunctly with their peers to ensure

consistency across the function in conducting risk oversight to identify potential

risks and control strategies. This role is responsible for the assessment of risk and

data quality analytics that monitor issues and identify emerging risks in studyspecific

variables (trends / outliers / unusual patterns) through the review of

aggregate clinical and operational data leveraging powerful statistical

methodologies.

The Sr Mgr I CTRA will be responsible for study-level risk analysis and reporting

and will be key contributor to the clinical study team to support the oversight of

the sites/countries/studies for compliance, patient safety, data quality and

reliability.

The Sr. Mgr I CTRA role has accountability to evaluate, monitor, escalate and

report risks to the Clinical Trial Risk Lead (CTRL) that could potentially have a

broad significant and/or systemic impact on quality, compliance, and operational

deliverables for discussion with the relevant Governance Committee.

The Sr. Mgr I CTRA forms a key partnership with the CTRL, R&D Quality (Risk

Governance and Operations), applicable GDO & TA functions.

Duties/Responsibilities • Sr. Mgr I CTRA to contribute to, and for assigned studies may lead, the

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

Manager (GTM) or 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

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Page 2 of 4

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

for assigned studies, drafting specifications independently.

• 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 applicable functional plan.

• Responsible for regular risk monitoring at study level 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, and periodically lead, 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 analytical insights back to the

original risk discussions to share a compelling 'risk story'.

• Drives 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.

• Participates in initiatives / continuous improvement opportunities within the

TRIM and broader organizations, with occasional leadership of select

departmental initiatives.

• 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.

• Supports onboarding of new team members and provides informal guidance

and peer mentoring within the TRIM group.

• Takes on additional responsibilities as directed by leadership.

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Page 3 of 4

Reporting Relationship This role will report to a people leader within the Clinical Trial Risk

Management (CTRM) 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; is

required.

At least 4 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.

Strong working expertise in 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.

Strong understanding of GCP, compliance and regulatory expectations.

Experience of audits and health authority inspections, root cause analysis and

CAPA is preferred.

Proven leadership skills with an ability to influence and manage key internal

stakeholders, with growing capability to engage and influence at senior stakeholder

level.

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 decision making and 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.

Section 3: Employee Signature

Wet signature required unless an approved electronic signature is available.

BMS ID Print Name Signature Date

Section 4: Manager Signature

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responsible for ensuring that they are printing or viewing the current version.

We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.

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.

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