Medpace needs experienced Quality Assurance (QA) professionals to support and audit global trials, ensuring adherence to organizational and regulatory standards.
Requirements
- Experience conducting audits of vendors and investigative sites;
- Experience hosting regulatory authorities and interacting with sponsor/client representatives;
- Knowledge and application of Good Clinical Practice (GCP) is required;
- Medical Device and or Phase 1 experience is a plus;
- Assess validated state and security of proprietary and cloud based software.
Responsibilities
- Act as a Quality Program Lead on clinical trials by supporting national and international regulatory standards and guidance for pharmaceuticals, biologics and medical devices.
- Develop audit management plans and audit strategy with clients for ongoing clinical trials.
- Coordinate and conduct internal system audits and external investigative site/vendor audits in accordance with Good Clinical Practice (GCP) guidelines;
- Participate in the development of departmental standard operating procedures, work instructions, forms, and templates;
- Assess validated state and security of proprietary and cloud based software.
- Develop training materials and applicable interactive tests and proficiency training including company-wide regulatory training (ICH/GCP);
Other
- Bachelor’s degree in life sciences or related field;
- 2-5 years of experience in a QA department in a related industry;
- Independent thinking and planning ability;
- Ability to travel up to 30%-40% of time;
- Excellent written and verbal communication skills;
- Exceptional teamwork skills;
- Ability to work independently.
