Sr. Clinical Data Manager at Bristol-Myers Squibb

Warsaw, Masovian Voivodeship, Poland

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, HealthcareIndustries

Requirements

Bachelor’s Degree required. Life sciences, Pharmacy or relevant fields preferred
4 years of experience in Clinical Data Review tasks
Able to work on clinical data review tasks
Able to work collaboratively on multi-disciplinary project teams
Strong 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
Strong oral and written communication skills
Travel Required Yes, 5-10% Industry Conferences, Investigator Meetings, Regulatory Inspections (as needed)

Responsibilities

Understand and review Protocol along with relevant study specific data review documents
Provide input to data review documents like Protocol Data Review Plan, Data Quality Management Plan
Review clinical data listings and prioritize critical data review
Manage and facilitate resolution of data discrepancies
Perform data cleaning as per the defined Clean Patient Group
Freezing & Locking of CRFs/Fields
Coordinate with Data Management Lead for study deliverables
Track data load and address discrepancies
Complete review of loaded external data and prioritize complex external data review e.g. Blinded Independent Committee Review, Biomarker, SAE
Coordinate with external data vendor for resolution of data discrepancies as applicable
Filing of appropriate documents in eTMF as per eTMF master plan
Provide Training and mentoring to junior CDM staff

Skills

Key technologies and capabilities for this role

Clinical Data ManagementData ReviewProtocol ReviewData CleaningCRF FreezingData LockingData Discrepancy ResolutionExternal Data ReviewData Quality ManagementData Listings Review

Questions & Answers

Common questions about this position

Is this a remote or office-based position?

It is a full-time office-based position with flexibility to work remotely up to 50% of the time over 2 weeks.

What are the key responsibilities of the Senior Clinical Data Manager?

Responsibilities include data review tasks such as reviewing protocols and data listings, managing data discrepancies, handling external data, documentation in eTMF, and providing training to junior staff.

What qualifications and experience are required for this role?

A Bachelor’s Degree is required (life sciences, Pharmacy or relevant fields preferred), along with 4 years of experience in Clinical Data Review tasks, strong knowledge of EDC systems like Medidata RAVE, and FDA/ICH guidelines.

What is the company culture like at Bristol Myers Squibb?

The culture is challenging, meaningful, and life-changing, with uniquely interesting work, opportunities to grow alongside high-achieving teams, and emphasis on balance and flexibility.

Is there travel required for this position?

Yes, travel is required at 5-10% for Industry Conferences, Investigator Meetings, and Regulatory Inspections as needed.

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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