Clinical Quality Associate Director

[Role description]

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person. At the heart of AstraZeneca, our team is committed and encouraged to follow the science. Driven by our curiosity, passion, and determination, we are paving the way to change the practice of medicine in Oncology.

The Clinical Quality Associate Director (CQAD) in general, is responsible for the maintenance and further development, and the communication of high-quality standards in the delivery of 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.

[Typical Accountabilities]

• Provides advice to Local Study Teams on AstraZeneca's 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 proficient 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.
• 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.
• 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.
• Shares learnings from local audits and inspections with local staff and with regional CQAD network, shares global/regional learnings with local staff.
• Is a key contact in the evaluation and management of fraud/poor quality cases, communicating with Quality Assurance (QA), and local management, as required.
• Supports implementation of global procedures and systems on local level by:
• providing review comments to global procedural documents where requested.

[Critical Requirements]

• At least 5 years of proven relevant experience.

[Skills]

• Ability to work in an environment of remote collaborators.
• Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.
• Good analytical, problem solving, negotiation and conflict resolution skills.
• Demonstrated ability to set and manage priorities, performance targets and project initiatives in a global and regional environment.

[Qualifications]

• Education: Bachelor’s degree (preferably in life science).
• Language: English
• Certifications: While specific certifications are not mandatory, relevant certifications such as ICH-GCP, ISO 9001, or CCRP are preferred
• Work Experience: 5 years experience in a GCP regulated environment with experience in clinical trial management and investigator site compliance.
• Competencies: Good knowledge of international guidelines ICH-GCP as well as relevant local regulations.
• Strong understanding of the drug development process and related GXP activities.
• Solid understanding of the skills and knowledge required for the successful delivery of a clinical study, e.g., ICH-GCP, study management, site management, monitoring.
• Excellent knowledge of spoken and written English.
• Good ability to learn and to adapt to work with IT systems.
• Ability to travel nationally and internationally as required.