Clinical Quality Assurance Officer
CurrentTransgene is a biotechnology company focused on designing and developing targeted immunotherapies for the treatment of cancer. Transgene’s programs utilize viral vector technology with the goal of indirectly or directly killing cancer cells.- Review, write and approve quality documents such as Standard Operating Procedures (SOPs) for Clinical Development and ensure their application. - Review documents related to clinical trials (protocol, Clinical Study Report, ICF, DSUR, IB… Show more Transgene is a biotechnology company focused on designing and developing targeted immunotherapies for the treatment of cancer. Transgene’s programs utilize viral vector technology with the goal of indirectly or directly killing cancer cells.- Review, write and approve quality documents such as Standard Operating Procedures (SOPs) for Clinical Development and ensure their application. - Review documents related to clinical trials (protocol, Clinical Study Report, ICF, DSUR, IB, regulatory documents,...). - Manage the regulatory intelligence, follow up the impact analysis and actions implemented until resolution. - Follow-up of actions to comply with the new European regulation (CTR No 536/2014). - Participate in the implementation of annual clinical audit plan based on a risk-based approach. - Perform internal (process) and external (investigator sites, external service providers, central laboratories...) GCP audits to ensure compliance with protocols, SOPs, GCP and applicable regulations. - Follow-up action plans (CAPA) related to internal and external audits. - Implement and review of clinical trials Quality Risk Management Plans (QRMPs) and Quality Tolerance Limits (QTL). - Report and follow-up deviations related to clinical activities. - Train the Clinical Development representatives and any other collaborators involved in Clinical Research activities. - Participate in defining the annual GCP training plan.- Take part in cross-functional clinical research projects involving various departments, such as Legal Affairs and System Quality Assurance. Knowledge of applicable clinical research regulatory requirements i.e., Good Clinical Practice (GCP) and International Conference of Harmonization (ICH). Show less
