Healthcare: Clinical Quality Manager (GCP) - Arlington, Virginia - (Arlington, VA)

Plan and lead GCP audits (international and domestic), including clinical investigator sites, contract clinical laboratories, and CROs to determine compliance status and identify compliance risks. Assess GCP compliance risk areas and develop and implement risk mitigation measures. Ensure compliance with companys procedures and regulatory qualifications. Conduct QA reviews of project-related Clinical Development essential documents (e.g. protocols, amendments, case report forms, tables and listings, informed consents, investigator brochures, and Clinical Study Reports). Review and provide input in to non-clinical documentation (e.g. protocols, study reports). Facilitate GCP training of functional areas and develop appropriate training for personnel involved in the execution of clinical trials and nonclinical studies. Participate in the evaluation and selection of CROs and other clinical and nonclinical service providers.