Associate Director, TMF Operations and Clinical Operations Analytics
Remote job
R
USD 142K-190K (estimate) Senior-level Contract Full Time
Tasks
- Assess analytics reporting systems for risk mitigation
- Communicate performance metrics to leadership
- Create clinical metrics and KPIs reports
- Develop Clinical Operations reporting strategy
- Develop TMF standards and SOPs
- Develop and present TMF metrics and KPIs
- Ensure inspection readiness
- Ensure reporting solutions are accurate scalable and aligned
- Interpret metrics and analytics
- Lead TMF governance committee
- Lead continuous improvement of TMF support model
- Manage Trial Master File vendors
- Map data for Clinical Operations reporting
- Negotiate and manage TMF vendor budgets
- Oversee Trial Master File operations
- Serve as TMF systems representative for integrations
- 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 Operations Reporting | Clinical metrics | Clinical operations | Data Mapping | Document Management | EDC | EDMS | Electronic Trial Master File | ICH GCP | Inspection Readiness | KPIs | Master File | Microsoft Excel | Microsoft PowerPoint | Microsoft Project | Microsoft SharePoint | Microsoft Word | Operations reporting | Reference Model | Risk Management | SOP Development | Trial Master | Trial Master File | Veeva Vault | Vendor management
Education
Bachelor of Engineering | Bachelor of Science | Master of Science
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