The Clinical Quality Manager (CQM) is 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 Site Management & Monitoring team are fulfilled in cooperation with the leadership team.

The CQM provides compliance and process advice to their local SMM team, 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. 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 tackle additional responsibilities or other roles such as Local Study Manager or line manager (Associate Director SMM), or key global/regional assignments as agreed with local and/or regional SMM 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 proficient advice on local regulations related to clinical trials, keeps abreast of changes in it and keeps local teams and local processes updated.
• Supports local management in the planning and conduct of local quality control activities as described in 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 team.
• 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 on the resolution of the findings audit and inspection in reports. Gives feedback with SMM staff, shares learnings.
• Identifies and ensures resolution of potential risks based on previous study/systems QC 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: induction 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 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 training materials are adequate, providing input/comments, coordinating/providing local face to face training, collecting and raising 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.
• When needed, raises questions to RCQAD, QA, Process Owners.
• Collaborate with partners: 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 professionals’ 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.

• Bachelors degree in related subject area, preferably in life science, or equivalent qualification.
• At least 5 years of experience in the pharmaceutical industry, preferably in Development Operations/Quality Assurance.
• Good knowledge of international guidelines ICH-GCP as well as 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 organisational skills, ability to prioritize and balance multiple tasks.
• Excellent verbal and written communication skills, attention to details.
• Good presentation skills.
• Integrity and high ethical standard.
• Positive approach for self, team and the business, where change is an opportunity to improve performance and added value to the business.
• Excellent knowledge of spoken and written English.
• Good ability to learn and to adapt to work with IT systems.