Description
Syneos Health is seeking a Sr Professional Quality Management with GCP experience. The successful candidate will perform various activities related to Good Clinical Practice (GCP) and related topics for Clinical departments.
Job Responsibilities
The Sr Professional Quality Management will:
- Support Clinical Monitoring (CM) teams through site audits
- Work with CM teams to prepare for site audits, including quality checks on training documentation, TMF, and study documents
- Assist CM teams during audits and inspections to determine underlying issues, perform root cause analysis, and formulate corrective and preventative actions
- Provide quality support and consultancy for Quality Management and Operations
- Ensure commitments and timelines for assigned activities adhere to Syneos Health and customer requirements
- Offer solutions to process and quality-related issues and identify process improvement opportunities
- Serve as a key resource within a business area or discipline
Qualifications
- BA/BS degree in science or healthcare or equivalent education and experience
- Experience in Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and/or Good Manufacturing Practice (GMP)
- Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint)
- Strong organizational, interpersonal, and team-oriented skills
- Ability to act independently and proactively
- Significant project management and customer management skills
Additional Information
Travel may be required (approximately 15%).