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Job #02770

About our client Our client is a global pharmaceutical company headquartered in Wilmington, North Carolina, that is focused on the development and commercialization of various therapeutics for Parkinson's disease. The company has an experienced management team, a varied selection of interesting protocols and an empowering corporate culture that is focused on the long-term professional development of its employees. Position Location Clinical Quality Assurance Manager/Associate Director North California Salary Highly competitive package, commensurate with experience Responsibilities 1) Perform maintenance reviews of company SOPs related to compliance with GCP, international and national regulations 2) Approve and archive all company SOPs related to compliance with GCP, international and national regulations 3) Review and maintain company archives of all current and prior clinical protocols 4) Conduct QA internal audits of all aspects of the Clinical Research Department’s activities to ensure compliance with applicable GCP, international and company procedures 5) Perform QA audits of clinical research investigator sites, CROs and vendors (as needed) 6) Ensure that any necessary corrective activity is implemented and completed according to agreed time schedules 7) Perform QA reviews of protocols and other documents and data in preparation for submission to IRB/IEC, regulatory health authorities and publications 8) Provide training to all personnel involved in Clinical R&D activities on GCP, ICH and local regulations (as required) 9) Generate, maintain and manage documents and training records of the activities of the Clinical Research Department 10) Issue periodic (usually monthly) reports to the QA Director, summarizing the activities of the QA Clinical Manager 11) Create and issue annual report summarizing the previous year's activities, changes in the QA program, suggestions for improvement in QA and projection of activities for the coming year 12) List and maintain records of all clinical trials on ClinicalTrials.gov in accordance with current regulations 13) Ensure compliance with company policies regarding utilization of healthcare providers as consultants Requirements 1) BA/BS in Life Sciences 2) Minimum 10 years of experience in a related pharmaceutical area 3) Ability to write cGCP documents 4) Ability to present educational material to small groups 5) Proficiency in MS Office 6) Willingness to travel within the United States, South America and Europe