Manager, Clinical Trial Risk Analyst

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Job Title / Role

Manager, Clinical Trial Risk Analyst

Department Name / Functional Area

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

Position Summary

The Manager, Clinical Trial Risk Analyst (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 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 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 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 Mgr CTRA forms a key partnership with the CTRL, R&D Quality (Risk Governance and Operations), applicable GDO & TA functions.

Duties / Responsibilities

• Mgr CTRA to 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 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 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.
• 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 relevant functional plan.
• Responsible for regular risk monitoring at study level for 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 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 or contributes to 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.
• 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
• 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 3 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.

Robust understanding of 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.

Robust understanding of GCP, compliance and regulatory expectations. Experience of audits and health authority inspections, root cause analysis and CAPA is desirable.

Strong leadership skills with an ability to influence and manage key internal stakeholders

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 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

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

Responsibilities

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.

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 [HIDDEN TEXT] . Visit careers.bms.com / eeo -accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

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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Skills Required

quality by design, Data Analysis, Veeva