Beeline Medicines
Biotechnology
Director,ClinicalDataManagement
“Director, Clinical Data Management at Beeline Medicines. Skills: Clinical Data Management, EDC systems, Regulatory compliance, Vendor oversight. Direct strategic direction of CDM activities. Oversee operational execution of CDM activities”
Industry & Context.
Root cause analysis; Corrective actions; Preventive actions
What They're Looking For.
Must Have
Bachelor's degree required, 10+ years clinical data management experience, Experience managing CDM activities, Experience with global regulatory submissions, Experience managing CRO relationships
Nice to Have
Advanced degree preferred, 3+ years vendor management experience, Experience in immunology therapeutic areas, Experience in early-stage biotech environment, Direct experience with health authority inspections
What You'll Do.
Direct strategic direction of CDM activities
Oversee operational execution of CDM activities
Drive continuous improvement of CDM activities
Shape data management strategy
Partner with cross-functional teams
Provide status updates to senior leadership
Oversee development of CDM study documents
Review CDM study documents
Direct EDC system implementation
Ensure timely data cleaning
Manage discrepancy resolution
Oversee medical coding
Reconcile external data sources
Lead database lock activities
Manage external vendor relationships
Oversee CRO activities
Review third-party vendor deliverables
Ensure CDM activity compliance
Integrate data management into study protocols
Support IND/NDA filings
Support audit preparations
Support regulatory inspections
Serve as CDM contact for inquiries
Implement corrective actions
Identify data quality risks
Implement mitigation strategies
Conduct root cause analyses
Drive corrective actions
Drive preventive actions
Perform other duties as assigned
How You'll Work.
Team & Collaboration
Cross-functional teams; Senior leadership; Clinical teams; Regulatory teams; Quality teams; External partners; CRO partners
Communication Scope
Present complex concepts; Written communication; Verbal communication
Process & Methodology
Project management, Manage multiple studies, Manage priorities
Applying for this Director, Clinical Data Management role?
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