Oncology Clinical Quality Associate Director

hace 4 semanas


Madrid, España AstraZeneca A tiempo completo

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) in general, is responsible for the maintenance and further development, and the 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 their local SMM team and identifies opportunities for quality and process improvements on local, regional and global level. 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 supports audits and inspections and is the main contact for auditors, inspectors for the local SMM team.

**Typical Accountabilities**
- An 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 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 organisation 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 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 organises/provides on-going and ad hoc training & re-trainings of local staff according to local training needs, in cooperation with local SMM leadership:

- introductory training to new staff, including Procedural Training.
- ad hoc local training solutions e.g. as result of serious or recurring quality issues.
- is involved in other local initiatives to identify and share best practices.
- Supports implementation of global procedures and systems on local level by:

- providing review comments to global procedural documents where requested.
- assessing if global training material is adequate for local use, providing input/comments to global training material authors, if required.
- organising/providing local face to face training for global procedures and systems, if required.
- collecting and escalating process/systems related questions from users.
- Providing required training relating to relevant global initiatives.
- 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.
- Coordinates the development, publication, training, implementation, maintenance and archiving of Local Procedural Documents, ensuring compliance with global Clinical Procedural Documents, applicable Quality & Compliance Manual documents, international guidelines such as ICH-GCP and local regulations.
- Acts as interface to/contact for QA.
- When needed, escalates related questions to RCQAD, QA, Process Owners, as appropriate.
- Acts as inte



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