Manager, Quality Control

Title: Manager, Quality Control

Location: Wayne, PA (Partial Remote)

Responsibilities:

• Performs non-programmatic QC of Biostatistical output (tables, listings, and figures)
• May complete database quality control audits of CRF data and query application.
• Provides input for Standard Operating Procedures in the QM Department.
• Supports Client Training Program and documentation thereof.
• Performs QC of trial master files.
• Conducts internal document QC reviews.
• May perform QC of Clinical Study Reports.
• Review of output from clinical test databases
• Coordinate update, review, approval and training assignments for Client standard operating procedures
• May participate in audits of 3^rd party vendors and in audits of Client

Requirements:

Ability to work in a team environment under strict deadlines.

Ability to effectively communicate with data management and programming personnel.

Experience/Education/Degree(s) Required:
Bachelor’s degree in health/life sciences (or equivalent theoretical/technical depth).

Demonstrated problem-solving and decision-making skills