job objective:
implement and maintain the r＆d qa strategy(quality issue/capa management, gcp inspection readiness, sop management, etc.) in ds china and improve the quality of the ｄｅｌiverables of the clinical operations.
specific responsibilities:
1. implement and maintain global r&d quality assurance(qa) strategy in ds china.
? facilitation of the implementation of the qa strategy/plan in ds china in close alignment with the clinical operations.
? advice and support of complying regulatory requirements and building them into the business process/procedures of clinical operations, if needed.
2. manage quality issues (qis) and capas in ds china
? oversight of key performance/quality indicators (kpis/kqis).
? support of escalations of qis and review of the qis according to relevant sops.
? facilitation of developing capa plan based on appropriate measures and ｅｘｅｃuting capas.
? check of capa effectiveness with the appropriate indicators.
3. facilitate gcp inspection management activities in china
? leadership of gcp inspection activities including the preparation and follow-up of the inspections in collaboration with internal and external stakeholders.
4. manage local r&d and qa sop life cycle management(lcm) and sop training in china
? lcm of local r&d sops in accordance with a relevant sop
? facilitation of sop ｕｐｄａｔｅs according changes of regulations and business circumstances
? development and ｕｐｄａｔｅ of local qa procedures based on the activities.
? ｅｘｅｃution of global/local sop training and keeping the training records
5. facilitate gcp training and other training related to r&d quality
? conduct of gcp-trainings and other trainings related to quality activities to clinical operations.
6. communicate with global and asia-pacific qa representatives
? communication with global/asia-pacific representatives as a china r&d qa representative.
experience and qualifications:
1. bachelor’s degree in life sciences, pharmacy or medicines required, ｍａｓｔｅｒ’s degree advanced degree in life sciences, pharmacy or medicines preferred.
2. four or more years of involvement in the area of gcp quality assurance in gcp qms.
3. understanding of expectations of key health authorities in management of clinical trials, ich/china gcp, qms, current clinical operations, etc.
4. profound understanding of the science of new drug development.
5. fluent in chinese and english language skill (written and verbal). asia-pacific languages (e.g., japanese) other than those listed above, if at all possible.
6. analytic and systematic approach with excellent problem-solving skills
7. proactive and reliable work ability in international matrix teams
8. ability to understand complex matters and work for continuous improvement
9. abundant communication skills, especially respect and understanding of cultural diversity, even on a cross-cultural level
10. flexible and adapｔａｂｌｅ
11. excellent communication skills and intercultural sensitivity.
12. effective project and time management skills and the ability to work under pressure

岗位职责：
this position is a member of the data management team and serves as a subject matter expert for clinical data programming, reporting, data visualizations, and supporting programming tools. specifically,
?manage the quality and ｄｅｌivery of the data management clinical database programming ｄｅｌiverables including edit checks programming, complex reports, and listings; patient profiles, subject narratives, exception listings, dose modification reports, and other adhoc reports as part of standard data validation and reporting package for clinical studies.
?provide oversight on the programming specifications for the data validation and reporting ｄｅｌiverables; code, test, and document ｄｅｌiverables conforming to programming standards, data quality and governance, and validation policies.
?partner with the study data managers to develop and confirm programming specifications, support adhoc external data reporting and listings needs, and manage quality expectations in collaboration with internal and external stakeholders.
?proactively identify and resolve issues that may influence and/or impact study quality and other ｄｅｌiverables.
?manage and mitigate quality and ｄｅｌivery risks to ensure adherence to timelines, and quality thresholds.
资历要求：
experiences:
- two or more years of clinical trial experience in the device/pharmaceutical/cro industry;
- expertise in clinical programming, methods, and techniques;
- expertise in the use of standard reporting and data visualization tools including spotfire, ｔａｂｌｅau, jreview and sas tools;
- knowledge of cdisc and cdash standards;
- knowledge and understanding of industry standard clinical technologies including edc, ctms, and irt.
competencies:
- programming methods and techniques
- work collaboratively with people at different levels of experience, different disciplines, and cultures
- self-directed; able to work independently
- critical thinking and complex problem-solving skills
- ability to manage multiple priorities
- background in programming development, project management, validation, ｅｘｅｃution, maintenance, documentation, and archival of clinical data
- expertise in supporting and handling external data; viewing and integrating data in multiple formats including sas
- knowledge of industry standards, medical terminology, and clinical trial methodologies

岗位职责：
act as a subject matter expert for the acquisition, oversight, and management of external data for all clinical studies. specifically,
? manage all quality ｄｅｌiverables for the timely acquisition and management of external data in accordance with our gsop/gsoi, external file transfer specifications, and electronic data transfer specifications and maintain inspection readiness of the documents in partnership with ds partners and the study data managers.
?ensure effective quality oversight on the ｄｅｌiverables from our cro partners and functional service providers engaged in the acquisition and management of external clinical data.
?proactively identify and resolve issues that may influence and/or impact study quality and other ｄｅｌiverables.
?work closely with the study teams to develop specifications, support adhoc external data reporting needs, and manage quality expectations in partnership with internal and external stakeholders, as needed.
?partner with the study data managers to facilitate in the quality review and acceptance of the external data in clinical data repository.
资历要求：
experience：
- two or more years of clinical trial experience in the device/pharmaceutical/cro industry;
- expertise in best practices of external data acquisition, integration, and management;
- knowledge of industry standard clinical technologies including ctms, edc, clinical data repository;
- knowledge of cdash and cdisc data standards;
- knowledge and understanding of data acquisition and integration tools and technologies.
competencies:
- work collaboratively with people at different levels of experience, different disciplines, and cultures
- self-directed; able to work independently
- strong communication, negotiation, and conflict resolution skills
- ability to manage multiple priorities
- background in clinical programming, project management, and data acquisition methods
- knowledge of data comparison methods and data integrity algorithms
- knowledge in supporting and handling external data; viewing data in multiple formats including sas
- knowledge of industry standards, medical terminology, and clinical trial methodologies