Senior Manager, Clinical Data Management

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Challenging. Meaningful. Life-changing. Those arent words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here uniquely interesting work happens every day in every department. From optimizing a production line to the latest breakthroughs in cell therapy this is work that transforms the lives of patients and the careers of those who do it. Youll get the chance to grow and thrive through opportunities uncommon in scale and scope alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits services and programs that provide our employees with the resources to pursue their goals both at work and in their personal lives. Read more: 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.

Key Responsibilities

• Provides clinical data management leadership within the study team toalign on and drivedata collection requirementsfor 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

Degree Requirements

• Bachelors 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 analysisand 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)

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If you come across a role that intrigues you but doesnt perfectly line up with your resume we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work Life-changing Careers
With a single vision as inspiring as Transforming patients lives through science every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture promoting global participation in clinical trials while our shared values of passion innovation urgency accountability inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential site-by-design field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles onsite presence is considered an essential job function and is critical to collaboration innovation productivity and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

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 . Visit to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff customers patients and communities. As a result the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

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

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