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Associate Director, Quality Assurance
Location:
Baltimore, MD
Description:
We are looking for an experienced Associate Director, Quality Assurance to join our team, onsite, in Baltimore, MD. This role will collaborate directly with the Sr. Director to lead our clinical research efforts and ensure compliance with Good Clinical Practices (GCPs). The ideal candidate will have a strong background in clinical research and a thorough understanding of quality assurance processes and GCPs. Day-to-Day Lead the development and implementation of quality assurance processes for Phase 1 clinical trials in accordance with GCPs. Oversee the management of study data, including data entry, data cleaning, and data analysis to ensure accuracy and completeness. Conduct regular audits of study sites to ensure compliance with GCPs and study protocols. Develop and implement training programs for study staff on GCPs and quality assurance processes. Review and approve study-related documents, including protocols, case report forms, and informed consent forms. Collaborate with study teams to resolve quality issues and ensure timely resolution of study-related non-compliance events. Develop and maintain quality metrics to track and improve the performance of the quality assurance program. Keep current with regulatory changes and requirements affecting clinical research and implement necessary updates to quality assurance processes. Education & Experience Bachelor's degree in a relevant field (e.g., life sciences, nursing, public health). Minimum of 7 years of experience in clinical research, with at least 5 years of experience in a quality assurance role. Experience may be substituted for educational requirements. Thorough understanding of GCPs and clinical trial processes. Excellent written and verbal communication skills. Ability to manage multiple projects and priorities in a fast-paced environment. Strong leadership skills and ability to motivate and mentor teams. Ability to work independently and as part of a team.
Company:
Pharmaron
Posted:
December 26 2023 on ApplicantPro
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More About this Listing: Associate Director, Quality Assurance
Associate Director, Quality Assurance is a Executive Associate Director, QA Job at Pharmaron located in Baltimore MD. Find other listings like Associate Director, Quality Assurance by searching Oodle for Executive Associate Director, QA Jobs.
Associate Director, Quality Assurance is a Executive Associate Director, QA Job at Pharmaron located in Baltimore MD. Find other listings like Associate Director, Quality Assurance by searching Oodle for Executive Associate Director, QA Jobs.