Job Description:

Manager, Clinical QualityRead all the information about this opportunity carefully, then use the application button below to send your CV and application.**Client is open to hiring CPM / CTM's or Clinical Operations individuals who are interested in Quality. Ideal experience in GCP is desired. This is an individual contributor role. ResponsibilitiesIdentify and prioritize audit strategies for GCP programsCoordinate, plan, and/or conduct clinical study-related audits (Investigator Sites, Clinical Service Providers, Internal Systems, etc.)Report audit findings to management with recommendations for resolution and verify appropriate corrective actions have been implemented/documentedConduct training for staff (GCP, Inspection Readiness training, etc.)Interview, select, and train employeesPrepare and host regulatory inspectionsWrite and review Standard Operating Procedure (SOPs)ExperienceMinimum of 6 years of experience in FDA- and ICH-regulated clinical research in GCP QA Detailed knowledge of and ability to interpret/apply GCP, EU, FDA, and ICH regulations/guidelinesAbility to critically analyze and communicate compliance-related information and present associated risksAbility to coordinate internal/contract auditors and conduct auditsExperience auditing Investigator sites, Clinical Service Providers, and Internal Systems AuditsExperience with regulatory inspection and inspection readinessExperience with Quality Management SystemsExperience reviewing study-related documentation (protocols, clinical study reports, informed consents) and communicate findings to appropriate team membersAbility to work independently, manage multiple priorities, and execute on goalsExcellent interpersonal and written communication skillsStrong analytical thinking with problem-solving skills and the ability to adapt to changing priorities and deadlinesTravel required - up to 20% (domestically and internationally)EDUCATIONMinimum of Bachelor's Degree in a scientific discipline required