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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
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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™ ”, e
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