Clinical EDC Database Reviewer - Marlborough, MA

K3-Innovations, Inc.; Marlborough (MA); Hybride; USD 65 000 - 85 000; Plein temps

Avantages offerts par ce poste

Medical insurance

Vision insurance

401(k)

Résumé du poste

A healthcare technology firm in Marlborough, MA is seeking a Clinical EDC Database Reviewer to work in a hybrid setting. The role requires 2 years of experience in life sciences or 1 year with a Master's degree. Responsibilities include reviewing clinical data for accuracy and compliance with industry standards. Benefits include medical and vision insurance, and a 401(k) plan.

Qualifications

• 2 years of experience with a life sciences BS degree or 1 year with an MS degree.
• General knowledge of industry practices and standards.

Responsabilités

• Review clinical data for completeness and accuracy.
• Maintain compliance with Good Clinical Practices.
• Provide clinical data to internal and external customers.

Connaissances

Life sciences knowledge

Understanding of GCP and GDP

Judgment and decision making

Data management expertise

Formation

Bachelor's degree in life sciences (2 years experience) or Master's degree (1 year experience)

Description du poste

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)