Short role description

The Clinical Quality Manager (CQM) 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.

The CQM 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 CQM 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.

The CQM supports audits and inspections and is the main contact for auditors for the local SMM team.

The CQM supports the local SMM leadership team in the planning and implementation of all quality control activities and uses risk management to evaluate compliance issues and develop solutions.  The CQM keeps abreast of any business compliance issues and works in close collaboration with Regional Clinical Quality Associate Director (RCQAD) and any key regional and global networks.

A CQM may take on additional responsibilities or other roles such as LSM or line manager (ADSMM), or key global/regional assignments as agreed with local and/or regional SMM Leadership.

CQMs might have different internal titles based on the experience level (Associate CQM, CQM, Senior CQM). The experience level depends on the years of experience, performance record, level of independence in the role, ability to take on additional tasks or tutor more junior colleagues. The SMM Country Head/Country Director may assign this internal title after confirmation with Cluster/Senior Director SMM (Region). This will only be applicable for countries which have been exempted to use tiered internal titles.

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, 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 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 interface with local stakeholders: legal advice, nominated signatory, GxP function for quality related topics.
• Cascades to local clinical organization any relevant new global developments, initiatives and information coming from other stakeholders: e.g. RCQAD, QA.
• Participates and contributes in the Clinical Quality Managers’ Network in their region, as applicable.
• Is involved in local regulatory or operational external experts’ groups, as required on country level.
• Provides 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.
• Provides training to Investigational Site staff on ICH-GCP and local regulations if support is required.

For LSM or ADSMM activities, refer to and acknowledge LSM or ADSMM Job Description.

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.