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 area
• Provides 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 area
• Works 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 area
• Works 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 area
• Provides expertise in solving complex programming requirements related to CDD
• Governs the China Clinical Data Management Systems global and program standards libraries for the therapeutic or technical area
• Leads projects to automate, simplify and innovate in order to ensure that the team is industry leading
• Supports the organization in defining the digital strategy for delivering future CDD activities
• Accountable for delivering CDD activities within budget for the managed therapeutic or technical areas
• Accountable for appropriate resourcing of managed therapeutic or technical areas
• Accountable for appropriate training of reporting teams within managed therapeutic or technical areas
• May act as backup for the China function leader of Clinical Database Development
• May be asked to perform programming, testing and specification writing activities in the CDD scope.
• Mentor and train Database Developers
• AZ 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 discipline
• Database development experience in the pharmaceutical industry working with clinical trial data.
• Experience in working with matrix organizations
• Excellent Clinical trial knowledge
• Excellent organizational and analytical skills and high attention to detail
• Excellent written and verbal communication skills, organized and ability to lead tasks from concept to delivery
• Excellent planning, resource and project management skills.
• Excellent understanding of clinical data system design / development / validation and system interoperability.
• Ability to work independently without close supervision
• Ability to work in a global team environment
• Vision to deliver digital strategy for Clinical Database Development
• Excellent knowledge of clinical and pharmaceutical drug development process
• State of the art understanding of data standards (CDISC) and practices as they apply to CRF design, clinical data tabulation, database development, data handling and reporting
• Excellent ability to work effectively with external partners
• Demonstrates professionalism, diplomacy, mutual respect and the ability to manage/value diversity and cultural differences and promote productivity through encouragement
• 5+ years experience with Medidata's Rave Study Build
• Experience in Medidata Rave Custom Functions
• Experience or knowledge of Rave Safety Gateway, TSDV, email alert set-up
• Experience with object-oriented programming using .NET technologies, C#, Visual Basic, MS SQL, SAS, Python, APEX, PL SQL, XML, Java an advantage
• Experience with reporting environments Crystal Reports, Business Objects, Tibco SpotFire, PowerBI, Tableau

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.