Manager, Quality Control- Clinical
Duties: Responsible for quality control management of Phase I/IIA clinical research at Frontage Clinical Services, Inc. (FCS).
Works with Operations Management and Investigators to design and implement a robust quality control system to reduce errors and assist in adherence to protocol and applicable regulations.
- Bachelor’s Degree in Nursing, Science, or related field (or equivalent)
- Relevant experience in Clinical Research and Quality Control
- Computer literate in Microsoft Office, Word, and Excel
- Excellent organizational and time management skills
- Outstanding interpersonal, communication and writing skills
- Extreme attention to detail and accuracy, precision oriented, in a highly regulated environment
- Minimum of three (3) years of clinical research experience in pharmaceutical, biotech, medical device and other life science industries or equivalent education and experience
- Conducts quality control review of informed consent procedures, adherence to study protocol, accuracy and completeness of clinical study data (case report forms) versus source documentation, adverse event reporting and other study data points.
- Initiates and manages quality metrics and trending analysis and presents findings to management appropriately.
- Evaluates procedures and processes affecting quality and proposes process improvement initiatives.
- Participates in development and review of departmental Standard Operating Procedures (SOPs), guidelines, and intradepartmental procedures.
- Participates in development and monitoring of Corrective and Preventive Action Plans (CAPAs) relating to quality issues. Performs effectiveness verification to ensure CAPAs were implemented.
- Works with management to ensure internal and external audit findings are addressed, deficiencies are corrected, and preventive actions are implemented.