Senior Manager, Clinical Data Management

Bristol Myers Squibb EU Policy; Warszawa; On-site; PLN 283,000 - 343,000; Full time

Job summary

Bristol Myers Squibb in Warsaw is seeking a Senior Manager, Clinical Data Management to lead data collection for complex clinical development projects and ensure high-quality, timely data delivery.

The role requires 5+ years of relevant industry experience, strong leadership, and expertise with EDC systems such as Medidata RAVE. Collaboration across cross-functional teams and vendor oversight are essential. This is a full-time, on-site position in Warsaw.

Qualifications

• Bachelor's Degree required; advanced degree preferred.
• Minimum 5 years of relevant industry experience.
• Project management certification (e.g. PMP) is desirable.

Responsibilities

• Provides clinical data management leadership within the study team to align on 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.
• Leads or supports data collection system integration and enforces data standard conventions and quality expectations for clinical data.

Skills

Cross-functional collaboration

Communication

Project management

Data management

EDC systems knowledge

Microsoft Office

Education

Bachelor's degree

Advanced degree preferred

Tools

Medidata RAVE

Job description

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

Position Summary

The Senior Manager, Clinical Data Management is a leadership role considered essential to the sustainability and success of the BMS R&D pipeline. This role will report into Director, Clinical Data Management or Associate Director, Clinical Data Management.

Position 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
• Lead or support 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

Qualifications & Experience

• Bachelor’s Degree required with an advanced degree preferred

Experience Requirements

• At least 5 years of relevant industry experience.
• Project management certification (e.g. PMP) is desirable.

Key Competency Requirements

• 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 and cross-functional teams
• Knowledge of submission requirements, [e.g. New Drug Application (NDA)/Biologics License Application (BLA)/Market Authorization Application (MAA)]

We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.

Compensation Overview

Warsaw - PL: zł283,330 - zł343,330

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. The final compensation will be determined based on demonstrated experience and in accordance with pay equity principles and applicable employment laws.

How We Work

Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.

Supporting People With Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [e-mail]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

For roles based in Los Angeles County only: If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If this posting is missing required information required by local law or incorrect, contact BMS at [e-mail] with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.

R1601831 : Senior Manager, Clinical Data Management