Bristol Myers Squibb
Pharmaceuticals
SeniorManager,ClinicalDataManagement
“Senior Manager, Clinical Data Management at Bristol Myers Squibb. Skills: clinical data management leadership, data collection requirements, clinical trial data, end to end clinical data management activities, quality and project oversight, third party vendor oversight, integration requirements for EDC, data standard conventions, quality expectations for clinical data, DM related study plans, Data Quality Management Plan, Data Validation Plans, Data Review Plan, eCRF Completion Guidelines, Data ”
What You'll Achieve.
delivers complete, high quality and reliable clinical trial data in a timely manner
Industry & Context.
What They're Looking For.
Must Have
Bachelor's Degree, At least 5 years of relevant industry experience, Sound knowledge of Clinical Drug Development Process, FDA/ICH guidelines and industry standard practices regarding data management, knowledge and experience of EDC systems, demonstrated knowledge of Microsoft Office skills, well versed in industry trends and emerging technologies supporting data collection, Exhibits expertise in metrics analysis and reporting methodologies
Nice to Have
advanced degree, Project management certification (e. g. PMP)
What You'll Do.
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
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 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
Safety Gateway). Enforces data standard conventions and quality expectations for clinical data per defined processes
reviews/revises DM related study plans including Data Quality Management Plan
Data Validation Plans
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
How You'll Work.
Team & Collaboration
Able to work collaboratively on multi-disciplinary project teams; develop productive relationships with external vendors; Communicate effectively with senior management and cross-functional teams; Chairs Data Quality Review meetings with cross functional study team members; Represents DM on cross-functional project teams & submission Teams
Communication Scope
Excellent oral and written communication skills; Communicate effectively with senior management and cross-functional teams
Process & Methodology
Project management certification (e. g. PMP) is desirable, Efficiently plans, coordinates, and delivers complete, high quality and reliable clinical trial data in a timely manner for assigned projects
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