Assoc Manager, CDM at Bristol-Myers Squibb

Warsaw, Masovian Voivodeship, Poland

Apply Now

Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, BiotechnologyIndustries

Requirements

Bachelor’s Degree required. Life sciences, Pharmacy or relevant fields preferred
6 years of experience in managing end to end Clinical Data Management tasks
Able to work on end to end Clinical Data Management 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
Strong project management skills
Willingness to travel 5-10% for Industry Conferences, Investigator Meetings, Regulatory Inspections (as needed)

Responsibilities

Draft EDC build timeline in collaboration with Data Management Lead
Perform DB build tasks by creating specifications for Database and EditChecks
Create test scripts and complete test data entry/UAT for Coding, SitePayment, Safety Gateway
Collaborate with Data Management Lead and facilitate startup meetings including, but not limited to, EDC build kick-off, Interactive eCRF Build and IRMs (Interactive Review Meeting) for database and Edit checks
Create and finalize study documents like Data Quality Management Plan, eCRF completion Instructions, Protocol Data Review Plan (PDRP) post study team review
Ensure all startup documents are completed as per SOP and filed in eTMF as per eTMF master plan
Plan/execute Post Production/Migration for the study (if any)
Coordinate with Clinical Data Managers for the execution of data review tasks
Coordinate with external data vendors for any escalations related to any vendor data
Support Clean Patient Group delivery along with Clinical Data Management staff
Update study documents as needed during the conduct of the study
Support DML to conduct Data Quality Review meetings
Provide Data Health Metrics to Data Management Lead as requested
Support Data Management Lead in planning and execution of database lock activities
Perform post lock activities, as needed
Support DML in project management tasks to make sure that study is delivered successfully as per the study timelines with quality
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 ManagementEDCDatabase BuildEdit ChecksUATeCRFData Quality ManagementTest ScriptsStudy Startup

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 main responsibilities in this role?

Responsibilities include study startup tasks like drafting EDC build timelines and creating specifications, study conduct activities such as coordinating data review and vendor escalations, study closeout support for database lock, project management, and documentation filing in eTMF.

What is the salary range for this position?

This information is not specified in the job description.

What is the company culture like at Bristol Myers Squibb?

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

What skills or experience make a strong candidate for this role?

Strong candidates will have experience in clinical data management tasks like EDC database builds, UAT testing, data review coordination, vendor management, and familiarity with study documents such as Data Quality Management Plans and eTMF filing.

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.

Land your dream remote job 3x faster with AI

Try Jobo Free