Sr. Manager, Clinical Trial Risk Analyst

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Position Summary:

The Senior Manager, Clinical Trial Risk Analyst (Sr. Mgr 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 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 remote assessment of risk and data quality analytics that monitor issues and identify emerging risks in

study-specific variables (trends / outliers / unusual patterns) through the review of aggregate clinical and operational data leveraging powerful statistical

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

Governance and Operations), applicable GDO & TA functions.

Duties/Responsibilities:

Sr. Mgr CTRA to lead or 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 Manager (GTM), 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.

Individuals printing or viewing a BMS controlled document from a source other than

the Electronic Document Management System are

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

 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 applicable functional plan.

 Responsible for regular risk monitoring at study level for priority studies 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

CORM 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

 Lead or 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 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.

 Leadership or 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

 Coach, mentor and develop new team members.

 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 one of the following disciplines or related

field: Life Sciences (preferred); Analytics; Data Science; Statistics; Business; is

required.

At least 5 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.

Demonstrated 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.

In depth understanding of GCP, compliance and regulatory expectations.

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

CAPA is preferred.

Advanced Leadership skills with an ability to influence and manage key internal

stakeholders including at the Senior Leadership 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 communicate the long-term benefits and importance of the change to

align stakeholders.

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

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If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.

R1603562 : Sr. Manager, Clinical Trial Risk Analyst