Typical Accountabilities:

Accountable for implement and oversight on standardization and harmonization between China EDC and AZ global Raw Data Standards in clinical database deliverables across clinical projects in the therapeutic or technical areaProvides Study level technical expertise to Global Study Team data management, medical, analysis and reporting and study management teams throughout all study start up activities in therapeutic or technical areaWorks in collaboration with the clinical project level representatives of other technical groups, data management, analytics and reporting to define harmonized requirements for delivering clinical studies across the therapeutic or technical areaWorks in collaboration with AZ global EDC developer and system SME for defining and maintaining therapeutic or technical area level standards related to clinical database development, especially for AZ China RAVE EDC.Ensures compliance to GCP, GAMP and other global guidelines in delivering clinical databases for clinical studies across the therapeutic or technical areaProvides expertise in solving complex programming requirements related to CDDGoverns the China Clinical Data Management Systems global and program standards libraries for the therapeutic or technical areaLeads projects to automate, simplify and innovate in order to ensure that the team is industry leadingSupports the organization in defining the digital strategy for delivering future CDD activitiesAccountable for delivering CDD activities within budget for the managed therapeutic or technical areasAccountable for appropriate resourcing of managed therapeutic or technical areasAccountable for appropriate training of reporting teams within managed therapeutic or technical areasMay act as backup for the China function leader of Clinical Database DevelopmentMay be asked to perform programming, testing and specification writing activities in the CDD scope.Mentor and train Database DevelopersAZ China RAVE EDC URL management and build the RAVE URL management standards process and guidance document

Requirements:

Bachelor's degree, preferably in computing or scientific disciplineDatabase development experience in the pharmaceutical industry working with clinical trial data.Experience in working with matrix organizationsExcellent Clinical trial knowledgeExcellent organizational and analytical skills and high attention to detailExcellent written and verbal communication skills, organized and ability to lead tasks from concept to deliveryExcellent planning, resource and project management skills.Excellent understanding of clinical data system design / development / validation and system interoperability.Ability to work independently without close supervisionAbility to work in a global team environmentVision to deliver digital strategy for Clinical Database DevelopmentExcellent knowledge of clinical and pharmaceutical drug development processState of the art understanding of data standards (CDISC) and practices as they apply to CRF design, clinical data tabulation, database development, data handling and reportingExcellent ability to work effectively with external partnersDemonstrates professionalism, diplomacy, mutual respect and the ability to manage/value diversity and cultural differences and promote productivity through encouragement5+ years experience with Medidata's Rave Study BuildExperience in Medidata Rave Custom FunctionsExperience or knowledge of Rave Safety Gateway, TSDV, email alert set-upExperience with object-oriented programming using .NET technologies, C#, Visual Basic, MS SQL, SAS, Python, APEX, PL SQL, XML, Java an advantageExperience with reporting environments Crystal Reports, Business Objects, Tibco SpotFire, PowerBI, Tableau

 

Date Posted

14-7月-2025

Closing Date

30-10月-2025

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.