Senior Manager, Clinical Data Management
Vor 2 Tagen
Bristol Myers Squibb
Location:Boudry, New Jersey
Job Category:Other
Job Reference:e6e57ac49e2f
Job Views:9
Posted:21.01.2025
Expiry Date:07.03.2025
Job Description:Description: Clinical Data Management key focus is to ensure data quality, integrity & completeness of all data types (eCRF and non eCRF) collected in BMS clinical trials from study start to database Lock.
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 may report into Director, Clinical Data Management or Associate Director, Clinical Data Management. This is an office-based position in BMS New Jersey or Boudry offices.
Responsibilities will include, but are not limited to:
- 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 ongoing 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.
FSP/CRO/Vendor Oversight:
- 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).
Continuous improvement initiatives:
- Provides the relevant support and input to continuous improvement activities within clinical data management.
- Provides support for CAPA implementation as required.
Degree Requirements: 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)].
Travel Required (nature and frequency): Yes, 5-10% Industry Conferences, Investigator Meetings, Regulatory Inspections (as needed).
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 an inclusive culture, promoting diversity 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 a diverse 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.
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