What are the responsibilities and job description for the Clinical EDC Database Reviewer - Arden Hills, MN position at K3-Innovations, Inc.?
*** This is a junior position ***
Hybrid setting (3 days office and 2 days home).
Experience Required:
- 2 Years exp with life sciences BS degree or 1 Year exp with MS degree.
- A developing professional.
- Working knowledge and application of business and technical concepts, procedures and practices.
- General knowledge of industry practices, techniques, and standards.
- General understanding of business unit/group function.
- Exercises judgment when interpreting company policies and procedures to resolve a variety of issues.
Responsibilities:
- Review clinical data for completeness, accuracy and consistency in accordance with the investigational plan.
- Develop and maintain data management documentation and guidelines in accordance with Good Clinical Practices (GCP) and Good Documentation Practices (GDP).
- Provide subject matter expertise to project team members during all phases of project life cycle.
- Provides accurate and timely clinical data to internal and external customers upon request.
- Develop, test, and maintain data management systems.
- Provide subject matter expertise prior, during and post internal and external audits and inspections.
- Maintain compliance with corporate, core and study-specific learning requirements.
