Precisionmedicinegroup · Bangalore, IndiaPrepare for this interview
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Position Summary: The Quality Review Specialist is responsible for performing periodic TMF Quality Reviews for assigned projects in a timely manner and with high quality. The Quality Reviews are used to evaluate the completeness status of study TMFs and are critical to ensuring TMFs are maintained in an audit-ready manner. The Quality Review Specialist will be assigned responsibility for the less complex and/or smaller studies in the Precision portfolio. Essential functions of the job include but are not limited to: Performs periodic TMF Quality Reviews for assigned projects in a timely manner and with high quality Ensures that TMF documentation related to periodic TMF Quality Reviews is generated and filed in the TMF. Informs the TMF Lead if the TMF is not updated with the information related to countries, sites, contacts and applicable TMF document requirements. Supported by Manager, monitors and escalates to the TMF Lead document processing issues and inconsistences, missing/incorrect documents filed by the Functional Leads, non-response of the Functional Leads related to periodic Quality Review requests or questions. During periodic Quality Reviews, supports updates to expected documents and opening of placeholders in TMF, where needed. Where possible, identifies potential training needs for all team members working in the TMF to encourage high quality and consistent maintenance of the TMF. Supported by Manager, identifies and escalates to TMF leadership studies at serious risk based on poor quality.
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