Manager, Clinical Trial Risk Analyst at Bristol-Myers Squibb

Hyderabad, Telangana, India

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, Clinical TrialsIndustries

Requirements

Assigned to a portion of the Bristol-Myers Squibb clinical trial portfolio and works with peers for consistency in risk oversight
Expertise in remote assessment of risk and data quality analytics, monitoring issues and emerging risks via aggregate clinical and operational data using statistical methodologies
Ability to evaluate, monitor, escalate, and report risks with potential broad, significant, or systemic impact on quality, compliance, and operational deliverables
Partnership with CTRL, R&D Quality (Risk Governance and Operations), and applicable GDO & TA functions

Responsibilities

Contribute to Protocol De-risking process, supporting identification of critical to success factors and critical to quality factors (including critical data and processes)
Collaborate with Data Management Lead (DML), Statistician, Global Trial Lead (GTL), Quality Lead, Clinical Trial Physician, Clinical Scientist, and other study team members to propose KRIs (standard and study-specific) and Quality Tolerance Limits (QTLs), including details on critical data, data source, data flow, review frequency, and external data transfer frequency
Lead and collaborate with the study team to develop specifications for setting up KRIs, Data Quality Assessments (DQA), and QTLs
Partner with DML and other data review functions to determine holistic data review strategy for the study and function-specific review objectives/analytics; document risk monitoring data analysis responsibilities in the relevant functional plan
Conduct regular study-level risk monitoring and provide holistic risk reports at agreed frequencies
Ensure appropriate escalations of emerging risks (including QTL deviations) to the CTRL for discussion at relevant governance bodies (e.g., Quality Council)

Skills

Risk Based Management

RBM

Clinical Trial Risk Management

Data Quality Analytics

Statistical Methodologies

Risk Assessment

Aggregate Data Review

Trend Analysis

Outlier Detection

Bristol-Myers Squibb

Develops and delivers biopharmaceutical medicines

About Bristol-Myers Squibb

Bristol Myers Squibb (BMS) develops and delivers medicines aimed at treating serious diseases, focusing on areas like cancer, autoimmune diseases, and heart conditions. The company conducts extensive research and development to create new drugs, which are sold after receiving regulatory approval. BMS also produces generic drugs, offering affordable alternatives that meet the same quality standards as their branded counterparts. What sets BMS apart from competitors is its dual focus on both innovative and generic medicines, enhancing access to healthcare. The company's goal is to improve patient outcomes while maintaining a commitment to sustainability and corporate responsibility.

New York City, New YorkHeadquarters

1887Year Founded

$33,706.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Flexible Work Hours

Hybrid Work Options

Professional Development Budget

Risks

Increased competition in oncology from emerging biotech firms like ArsenalBio.

BMS's lawsuit over the 340B Drug Pricing Program may lead to regulatory challenges.

Rapid AI and digital tech evolution may pose integration challenges for BMS.

Differentiation

BMS focuses on innovative cancer treatments through collaborations like ArsenalBio for T cell therapies.

The company emphasizes digital health technologies, enhancing clinical trial management and patient engagement.

BMS offers both innovative and generic medicines, increasing affordable healthcare solutions.

Upsides

BMS's partnership with Medidata enhances clinical research processes and patient outcomes.

The collaboration with AI Proteins advances novel miniprotein-based therapeutics, expanding therapeutic modalities.

BMS's global license agreement with BioArctic expands its portfolio in neurodegenerative diseases.

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