Senior Manager, Clinical Data Management jobs in United States
cer-icon
Apply on Employer Site
company-logo

Bristol Myers Squibb · 3 months ago

Senior Manager, Clinical Data Management

Bristol Myers Squibb is a leading biopharmaceutical company that is dedicated to transforming patients' lives through science. The Senior Manager, Clinical Data Management will provide leadership in clinical data management to ensure data quality and integrity for complex clinical projects, overseeing data management activities and collaborating with internal and external teams.

BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
check
H1B Sponsor Likelynote

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

Qualification

Clinical Data ManagementEDC SystemsProject ManagementFDA/ICH GuidelinesMetrics AnalysisContinuous ImprovementCoachingCommunication SkillsCollaboration

Required

Bachelor's Degree required
At least 5 years of relevant industry experience
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)]

Preferred

Advanced degree preferred
Project management certification (e.g. PMP) is desirable

Benefits

Health Coverage: Medical, pharmacy, dental, and vision care.
Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Paid Time Off

Company

Bristol Myers Squibb

company-logo
At Bristol Myers Squibb, we work every day to transform patients’ lives through science.

H1B Sponsorship

Bristol Myers Squibb has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (247)
2024 (278)
2023 (231)
2022 (180)
2021 (181)
2020 (169)

Funding

Current Stage
Public Company
Total Funding
$29.32B
Key Investors
Venrock
2025-11-05Post Ipo Debt· $5.74B
2024-02-14Post Ipo Debt· $13B
2023-10-30Post Ipo Debt· $4.5B

Leadership Team

leader-logo
Charles Bancroft
CFO
linkedin
leader-logo
Cristian Massacesi
Executive Vice President, Chief Medical Officer and Head of Development
linkedin
Company data provided by crunchbase