Analyst II, Clinical Documentation Center Operations
Key Responsibilities Include:
- Involved with audit and inspection readiness activities by ensuring real-time inspection readiness on system-related items with CDC colleagues and artifact owners.
- Provides training/mentoring activities for current and new staff members.
- Presents metrics to CDC leadership.
- Conducts analysis on existing metrics/dashboards related to TMF Health, VAULT eTMF Document Processing, workflow timelines and other CDC-specific metrics.
- Proactively identifies areas for process improvement (i.e., suggest potential new metrics, provide recommendations for edits to SOP and Work Instruction); delivers new/enhanced metrics.
- Reviews and updates work instructions related to eTMF processes on a regular basis.
- Liaises with functional areas and provides coaching regarding VAULT processes and functionality.
- Complies with GCP, AbbVie SOPs and functional area processes.
- Bachelor degree or international equivalent is required; degree related to IT/Systems preferred.
- With at least 4 years Pharma experience or professional experience.
- Possesses good presentation and oral communication skills.
- Proven analytical and critical thinking skills.
- Functional and hands-on knowledge of electronic systems.
- Competent in application of clinical documentation business procedures.
- Operates independently.