Clinical Quality Manager SMM (QCM SMM)
- 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.
Competencies and Skills
- 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 organisational skills.
- Excellent verbal and written communication skills.
- Excellent ability to prioritize and handle multiple tasks.
- Excellent attention to details.
- Good presentation skills.
- 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 add value to the business.
- 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.
- 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 manage priorities, performance targets and project initiatives in a global and regional environment.
- Good cultural awareness.
[근무조건 및 환경]
- 복리후생 제공
[ 자격요건 ]
약학 / 제약학 / 생명과학 공학 / 유전공학 / 화학 / 생물학 학사학위 이상 취득자
해외여행의 결격사유가 없는 분
남자의경우병역필 / 면제인분
국어 / 영어 의사소통이 능통한 분
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 authorisation and employment eligibility verification requirements.