The Audit Coordinator provides guidance and facilitates the effective preparation, management and follow up of Sponsor Audits and Regulatory Inspections.
Key Accountabilities :
Work with Global team members to coordinate Sponsor audits; including preparation meetings, audit agendas, etcCollaborate with Sponsors (as assigned) to coordinate auditsArrange with other departments to gather necessary information on Sponsor confidentiality agreement documentation.
Assist in follow up and consultancy with clients, Parexel management, and staff.Build, develop, and maintain good working relationships with internal and external customer groupsTravel on assignment if neededAct as a contact with members of Regulatory Authorities and help support inspections in agreement with QA managementSupport the data entry of audit and inspection information into the SAIG database, i.
e. collection, QC and coordination of documents to be entered, feedback / questions to QA / operational staff, as well as tracking of audits, reports, and responses.
Contribute to the information provided to QA management to summarize quality issues arising from sponsor audits and other related activities, as requested.QualificationsSkills :
Ability to develop relationships with a culturally diverse group of key stakeholders within Parexel and the client’s businessExcellent interpersonal, verbal, and written communication skills, including experience in making presentations at conferences, meetings, and training sessionsExperience with Microsoft based applications and ability to learn internal computer systemsWillingness to work effectively with multiple supervisors in a matrix environment and to value the importance of teamworkAbility to work flexibly and adjust to changing priorities and unforeseen eventsDiplomatically address sensitive issues confidentially and professionallyAnalyze complex situations / issues and effectively communicate situations / issues, along with potential recommendations, to various functional groupsWork professionally with highly confidential information.
Knowledgeand Experience :
Significant experience in quality assurance, regulatory affairs, auditing, clinical research, monitoring, data management, pharmacy, laboratory, or other relevant area.Education :
Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experienceEnglish proficiency (written and oral English) in addition to fluency in local language.
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