Lead Clinical Data Analyst
US161 IN Warsaw - 700 Orthopaedic Dr, United States
USD 109K-174K Senior-level Full Time
Tasks
- Analyze change requests for study feasibility
- Coordinate UAT maintenance and closeout
- Coordinate clinical system implementation timelines and resources
- Create project management plans for trial study systems setup
- Create review and facilitate approval of system deliverables
- Define data and process standards
- Develop training materials for system setup and maintenance
- Evaluate and oversee vendor clinical systems
- Evaluate vendor release documentation for implementation feasibility
- Facilitate clinical systems support requests
- Implement study metrics
- Interface between clinical R and D IT and quality
- Lead deployment of CTMS
- Lead deployment of EDC
- Lead deployment of IxRS
- Lead deployment of eTMF
- Manage study go live as first line of contact
- Oversee development and management of clinical study databases
- Provide system deliverable routing and approval support
- Support harmonized processes for system support
Perks/Benefits
- N/A
Skills/Tech-stack
CDISC STDM | CTMS | Clinical Study Databases | Clinical data | Clinical data management | Clinical operations | Data Capture | Data Management | Data Quality | ETMF | Electronic Data | Electronic data capture | GCP | IXRS | Medidata | Project Management | SDLC | UAT | Veeva | Vendor management
Education
Bachelor of Arts | Bachelor of Engineering | Bachelor of Science
Roles
Analyst | Clinical Data Analyst | Clinical Data Manager | Data Analyst | Data Manager | Manager
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