Clinical Quality Associate Director – Oncology Clinical Trials  

Location: Office based (3 days/week) : Horizon Place, Luton  

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering ground-breaking methods and bringing unexpected teams together.  

The Clinical Quality Associate Director (CQAD) ensures high-quality standards in clinical study delivery and oversees training needs for the local SMM (Site Management & Monitoring) team alongside SMM leadership. The CQAD provides compliance and process guidance, finds opportunities for improvement, and maintains up-to-date knowledge of relevant regulations. They lead local procedural documents, support audits and inspections as the main contact for auditors, and use risk management to address compliance issues. In collaboration with the Regional Director, Clinical Quality SMM (RDCQ) and regional/global networks, the CQAD may also take on additional roles or assignments as agreed with leadership.  

Typical accountabilities:  

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, stays ahead 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 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 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 feedback on audit and inspection findings to relevant SMM staff.  

Shares takeaways from audits and inspections with local staff and with regional CQAD network, shares global/regional findings 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), RDQM and local management, as the need arises.  

Identifies and organises/provides ongoing and ad hoc training of local staff according to local training needs, in collaboration 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 standard methodologies.  

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 advancing process/systems related questions from users.  

Providing required training relating to relevant global initiatives.  

Essential requirements:  

Previous Experience in clinical trial execution in context of site management or monitoring (e.g. CRA or local project management)  

Bachelor degree in related field, preferably in life science, or equivalent qualification  

Significant experience in the pharmaceutical industry, preferably in Site management and monitoring or Development Operations/Quality Assurance.  

Good knowledge of international guidelines ICH-GCP as well as relevant local regulations.  

Good understanding of the drug development process and related GXP activities.  

Good 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 attention to details.  

Integrity and high ethical standard.  

Manages change with a positive approach for self, team and the business. Sees change as an opportunity to improve performance and contribute to the business.  

Excellent knowledge of spoken and written English.

Ability to travel nationally and internationally as required.  

Desirable requirements:  

Ability to interact widely and effectively within the company at all levels.  

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 lead priorities, performance targets and project initiatives in a global and regional environment.  

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible! We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world!  

So, what’s next?  

Are you already envisioning yourself joining our team? Good, because we can’t wait to hear from you.  

Date Posted

27-Aug-2025

Closing Date

07-Sept-2025

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.