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 current 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

Stakeholders including at the Senior Leadership Level

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.

📌 Sr. Manager, Clinical Trial Risk Analyst (Telangana)
🏢 Bristol-Myers Squibb
📍 Telangana