At AstraZeneca, we believe in the potential of our people, and you'll develop beyond what you thought possible. We make the most of your skills and passion by actively supporting you to see what you can achieve no matter where you start with us. The Oncology Clinical Quality Associate Director (O-CQAD) is responsible for the maintenance, further development, and communication of high-quality standards in the delivery of oncology clinical studies. This includes a key role in ensuring that the training needs in the local SMM (Site Management & Monitoring) team are fulfilled in cooperation with the local SMM leadership team.
This role provides compliance and process advice to the local SMM team and identifies opportunities for quality and process improvements on local, regional, and global levels. The O-CQAD is responsible for the development, implementation, and continuous review of local procedural documents, and maintains current knowledge and understanding of local regulations and industry practices in relation to clinical trials. They will support audits and inspections and be the main contact for auditors and inspectors for the local SMM team.
Typical AccountabilitiesAn O-CQAD may take on additional responsibilities or other roles such as LSAD or line manager (D-SMM), or key global/regional assignments as agreed with local and/or regional SMM Leadership.Provides advice to Local Study Teams on AZ procedural framework including global clinical processes, procedural documents, applicable Quality & Compliance manual documents, and on international guidelines such as ICH-GCP, industry standards, and local regulations.Provides competent advice on local regulations related to clinical trials, keeps abreast of changes in local regulations related to clinical trials, and keeps local teams and local processes updated.Ownership of local procedural framework.Supports local management in the planning and conduct of local quality control activities as described in the local annual quality plan, including performing accompanied site visits. Performs any required QC visits/QC activities with local staff and maintains the annual quality plan updated.Provides local management with information regarding the status of quality observed in the local SMM.Collaborates with and supports local study teams to resolve quality and compliance issues.Reviews regularly Protocol Deviations and ensures Quality Issues are reported within the appropriate timelines to local authorities and in AZ internal review systems according to AZ QI process.Supports the local organization in the preparation for, conduct of, and responses to audits and regulatory inspections.Advises Local Study Teams on the resolution of the findings in audit and inspection reports. Gives regular feedback on audit and inspection findings to relevant SMM staff.Shares learnings from local audits and inspections with local staff and with the regional CQM network, shares global/regional learnings with local staff.Identifies and ensures resolution of potential risks based on previous study/systems QC results, audit and inspection results, and current routine quality management work.Is a key contact in the evaluation and management of fraud/poor quality cases, communicating with Quality Assurance (QA), RCQAD, and local management, as required.Identifies and organizes/provides ongoing and ad hoc training & re-trainings of local staff according to local training needs, in cooperation with local SMM leadership.Supports implementation of global procedures and systems on local levels by providing review comments to global procedural documents where requested.Contributes to the local implementation of systems and tools related to the delivery of clinical operational tasks or SOPs, ICH-GCP requirements, e.g., CTMS, eTMF, LMS, Toolboxes, reporting tools, and dashboards, etc.
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