Senior Manager, Clinical Data Management at Bristol-Myers Squibb

Warsaw, Woj. Mazowieckie, Poland

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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 required (advanced degree preferred)
At least 5 years of relevant industry experience
Project management certification (e.g., PMP) is desirable
Able to work collaboratively on multi-disciplinary project teams and develop productive relationships with external vendors
Sound knowledge of Clinical Drug Development Process, FDA/ICH guidelines, and industry standard practices regarding data management
Strong knowledge and experience of EDC systems (Medidata RAVE preferred); demonstrated knowledge of Microsoft Office skills and well versed in industry trends and emerging technologies supporting data collection
Strong project management; exhibits expertise in metrics analysis and reporting methodologies
Excellent oral and written communication skills
Communicate effectively with senior management

Responsibilities

Provides clinical data management leadership within the study team to align on and drive data collection requirements for one or more complex clinical development projects
Efficiently plans, coordinates, and delivers complete, high quality and reliable clinical trial data in a timely manner for assigned projects
Responsible for end-to-end clinical data management activities and serves as a primary point of contact for internal and external study team members
Provides strong quality and project oversight over third-party vendor responsible for data management deliverables
Takes a leadership role to gather content and integration requirements for EDC and close collaboration with partners supporting other data collection systems (eCOA, External Data, Safety Gateway). Enforces data standard conventions and quality expectations for clinical data per defined processes
Authors, reviews/revises DM related study plans including Data Quality Management Plan, Data Validation Plans, Data Review Plan, eCRF Completion Guidelines and other study documents to ensure quality and standardization
Chairs Data Quality Review meetings with cross-functional study team members to ensure on-going review of trial data currency, quality and completeness
Represents DM on cross-functional project teams & submission Teams
Leads or supports the Health Authority inspections and audits
Provides coaching and quality oversight of junior Data Management Leads
May act as core member of the study team and provides FSP/CRO/Vendor oversight for end-to-end Data Management activities, manages data currency throughout the trial, and overall monitoring DM deliverables according to the Service Level Agreement (SLA)
Provides the relevant support and input to continuous improvement activities within clinical data management
Provides support for CAPA implementation as required

Skills

Clinical Data Management

EDC

eCOA

Data Collection

Vendor Management

Clinical Trials

Data Integration

Project Oversight

R&D Pipeline

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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