Associate Director, TMF Operations and Clinical Operations Analytics
Philadelphia, Pennsylvania, United States
USD 137K-190K (estimate) Senior-level Contract Full Time
Tasks
- Assess analytics and reporting systems risks
- Communicate KPIs to stakeholders
- Develop Clinical Operations reporting strategy
- Develop TMF standards and SOPs
- Develop and present TMF KPIs
- Ensure data mapping accuracy for KPIs
- Ensure inspection readiness
- Ensure reporting solutions are aligned and scalable
- Generate clinical reporting metrics and KPIs
- Implement and govern TMF support model
- Interpret metrics and analytics
- Lead TMF operations strategy
- Lead governance committees with TMF vendors
- Manage TMF vendor budgets and spend
- Manage resources and staff training
- Oversee TMF vendors and processes
- Oversee clinical trial phase documentation requirements
- Review TMF input for clinical documents
- Serve as TMF systems interface representative
- Support audits and regulatory inspections
Perks/Benefits
- N/A
Skills/Tech-stack
Adobe Acrobat | Analytics | Audit Support | CDISC Trial Master File Reference Model | CDMS | CTMS | Clinical Reporting | Data Governance | Document Management | EDC | EDMS | Electronic TMF | ICH GCP | ISF | Inspection Readiness | Master File | Metrics and KPIs | Microsoft Excel | Microsoft PowerPoint | Microsoft Project | Microsoft SharePoint | Microsoft Word | Reference Model | Regulatory Compliance | Risk Management | SOP Development | Trial Master | Trial Master File | Trial Master File Reference Model | Veeva Vault | Veeva applications | Vendor management
Education
Regions
Countries
States
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