Associate Director, TMF Operations and Clinical Operations Analytics
Philadelphia, Pennsylvania, United States
USD 137K-190K (estimate) Senior-level Contract Full Time
Tasks
- Assess systems supporting analytics and reporting
- Communicate performance metrics to stakeholders
- Create metrics KPIs and analytics
- Develop TMF standards and SOPs
- Develop clinical operations reporting and analytics
- Ensure inspection readiness for audits
- Ensure reporting analytics solutions alignment and scalability
- Generate and present TMF metrics KPIs
- Govern TMF vendor committees
- Interpret metrics and analytics
- Lead TMF support model evolution
- Manage TMF vendors and processes
- Negotiate and manage TMF operations budgets
- Oversee Trial Master File operations
- Oversee data mapping for Clinical Operations reporting
- Provide TMF input to clinical documents
- Represent TMF operations for system integrations
Perks/Benefits
- N/A
Skills/Tech-stack
Analytics | Audit Support | CDISC Trial Master File Reference Model | CDMS | CTMS | Clinical Operations Reporting | Clinical operations | Data Mapping | Document Management | EDC | EDMS | Electronic TMF | ICH GCP | Inspection Readiness | KPIs | Master File | Metrics | Operating procedures | Operations reporting | Project Management | Reference Model | Regulatory Compliance | Risk Management | Standard Operating Procedures | Trial Master | Trial Master File | Trial Master File Reference Model | Veeva Vault | Veeva applications | Vendor management
Education
Bachelor of Arts | Bachelor of Engineering | Bachelor of Science | Master of Science
Regions
Countries
States
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