Clinical EDC Database Reviewer - Marlborough, MA

Clinical EDC Database Reviewer - Marlborough, MA

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.
• 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.

Seniority level

• Associate

Employment type

• Full-time

Job function

• Research

Benefits

• Medical insurance
• Vision insurance
• 401(k)