Associate Director, Clinical Data Management at Bristol-Myers Squibb

San Diego, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, Biotechnology, HealthcareIndustries

Requirements

Bachelor’s degree in Life Science, mathematics, or health-related fields preferred
Minimum of 6 years data management experience in pharmaceutical/biotech/CRO industry; extensive hands-on experience in all aspects of data management
Experience in the Oncology therapeutic area is preferred
Proven ability to manage CRO relationships and oversee data management deliverables
Strong knowledge and experience of EDC systems (Medidata RAVE preferred)
Solid knowledge of GCP, CDISC/CDASH data structures, ICH guidelines and FDA regulations
Excellent verbal and written communication skills
Strong analytical and problem-solving abilities
Proficient in clinical systems including EDC, IVRS, CTMS, eTMF, and other clinical project management tools; ability to learn new systems as needed
10% of travel required

Responsibilities

Provide data management leadership, insight, and support to all internal and external projects and clinical trials
May simultaneously function as lead Clinical Data Manager for multiple clinical trials
Responsible for ensuring the data collected meets the requirements of the study objective and company quality standards
Manage and provide oversight of data management personnel and activities of CROs and vendors
Ensure CRO adherence to project timelines, from study startup to study closeout, while maintaining high quality and integrity of deliverables
Engage in cross-functional meetings, providing updates on project status, issues, and milestones
Review data using listings and visualization tools for performance and quality reporting, conducting reviews within studies and across multiple studies for trend analysis
Lead interactions with third party vendors (e.g., clinical laboratories) on collection, transmittal, and transfer of study specific data
Contribute to SOP development and updates to meet regulatory compliance and operational needs

Skills

Clinical Data Management

Data Integrity

Clinical Trials

Data Quality Control

Cross-Functional Collaboration

Project Leadership

Study Objectives

External Partner Management

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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