Manager, Clinical Trial Risk Analyst
Bristol-Myers Squibb · Hyderabad · onsite · Posted 41d ago
Undisclosed3–8 yrsfulltimeSourced from
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About this role
Responsibilities
Reporting Relationship
Qualifications
Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
- 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 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.
Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
Sourced from naukri
Skills
data qualityDocument Managementdrug developmentcritical to qualitydata privacylosgoogle cloud platformauditsdata transferCAPAAnalyticsData ReviewGoogle DataFlowData Managementmaintenancedata analysiscomplianceLife SciencesData Science
About Bristol-Myers Squibb
Bristol-Myers Squibb
Pharma
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About
We are a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. At Bristol Myers Squibb, we work every day to transform patients’ lives through science. We combine the agility of biotech with the reach and resources of an established pharmaceutical company to create a global leading biopharma company powered by talented individuals who drive scientific innovation.
We have the brightest people in the industry and believe that their diverse experiences and perspectives help to bring out our best ideas, drive innovation and achieve transformative business results. Each day, our employees around the world work together for patients – patients are at the center of everything we do. They inspire us. They are the reason we come to work each day.
We are proud of the advancements we have made in oncology, hematology, immunology, and cardiovascular disease, and we are dedicated to helping patients prevail over serious diseases through our diverse and promising pipeline and new scientific platforms. We are pursuing therapies at the forefront of scientific discovery with the goal of bringing an exciting new generation of life-changing treatments to patients. We aspire to be at the center of a vibrant healthcare innovation ecosystem, where academic research centers, biotech, and biopharma companies all contribute to continued scientific advancement.
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