Clinical Quality Associate Director

3 weeks ago

Macquarie Park, Australia AstraZeneca Full time

Do you have experience in clinical operations and a passion for excellence? An exciting new opportunity to use your expertise to help us identify quality and process improvements within our newly formed Oncology Clinical Team

**About AstraZeneca**

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies.

Pioneers of collaborative research we have built an unrivalled scientific community both internally and externally. Fusing academia and industry, we have united some of the world’s foremost medical centres. Working seamlessly and inclusively, together we expedite research in some of the hardest-to-treat cancers.

We currently have an exciting 12 month contract opportunity for a Clinical Quality Associate Director in our SMM (Site Management & Monitoring) Team.

**What you’ll do**

As the Clinical Quality Associate Director (CQAD), you will be responsible for the maintenance, 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 team are fulfilled in cooperation with the local SMM leadership team.

You will provide compliance and process advice to the local SMM team and identify opportunities for quality and process improvements on local, regional and global level.

Reporting to the SMM Country Head, following are some of the key responsibilities in this role:

- Development, implementation and continuous review of local procedural documents including global clinical processes, procedural documents, applicable Quality & Compliance manual documents, and international guidelines such as ICH-GCP, industry standards and local regulations
- Maintain current knowledge and understanding of local regulations and industry practices in relation to clinical trials, ensuring the local teams and local processes are up to date
- Support for Audit and Inspections - support the local organisation in the preparation for, conduct of and responses to audits and regulatory inspections. Be the main contact for auditors for the local SMM team and advise the Local Study Teams on the resolution of the findings in audit and inspection reports
- Support the local SMM leadership team in the planning and implementation of all quality control activities and use risk management to evaluate compliance issues and develop solutions
- Advice to Local Study Teams on AZ procedural framework, support 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 maintain the annual quality plan
- Collaborate with and support local study teams to resolve quality and compliance issues
- Provide local management with information regarding status of quality observed in the local SMM
- Review regularly Protocol Deviations and ensure Quality Issues are reported within the appropriate timelines to local Authorities and in AZ internal review systems according to AZ QI process
- Be the key contact in the evaluation and management of fraud/poor quality cases, communicating with Quality Assurance (QA), RDCQRDCQ and local management, as required
- Identify and organise/provide on-going and ad hoc training of local staff according to local training needs, in cooperation with local SMM leadership and relevant to global initiatives
- Contribute 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.
- Act as interface to/contact for QA, with local stakeholders: legal advice, nominated signatory, GxP function for quality related topics
- Participate in and contribute to the Clinical Quality Associate Directors’ Network in the region, as applicable.
- Provide support, if required, to global teams in case of issues occurring in globally outsourced studies: support to local IEC clarifications, Insurance policy issues, serious breaches etc.

**Essential for the role**:

- Bachelor's degree or equivalent in a related discipline, preferably in life science
- Experience in Development Operations/Quality Assurance within the pharmaceutical industry
- 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, risk identification and risk based monitoring
- Excellent organisational skills along with an

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