Clinical Database Developer/ Certified RAVE Developer
- Experience Level
- Experienced (non-manager)
At AstraZeneca we are guided in our work by a strong set of values, and we're resetting expectations of what a bio-pharmaceutical company can be. By truly following the science, we pioneer new methods, new thinking and bring unexpected teams together. From scientists to sales, lab techs to legal, we're on a mission to turn ideas into life-changing medicines that transform lives. We need great people who share our passion for science and have the drive and determination to meet the unmet needs of patients around the world. If you're swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person.
Clinical Database Developer/Certified RAVE Developer coordinates the Clinical Database Development (CDD) deliverables on assigned clinical studies and may be an expert on CDD processes, standards and technology. Member of the Global Study Team (GST). Responsible to ensure CDD deliverables follow standards and meet data quality. Maintains Business Continuity for CDD processes and standards including integrity of the clinical database for the relevant studies.
- Coordinates and ensures timeliness and quality for creation of electronic Case Report Forms (eCRFs) according to finalized protocols and study design specifications for Electronic Data Capture (EDC) studies
- Coordinates and ensures timeliness and quality for creation of data entry screens according to the approved annotated Case Report Form (CRF) for paper studies
- Communicates with data management, medical, analysis and reporting and study management teams throughout all study start up activities to ensure team needs are understood and met.
- Coordinates and ensures timeliness and quality for the design, build and testing of clinical databases according to Standard Operating Procedures (SOPs) and guidelines
- Coordinates and ensures timeliness and quality for Programming of field derivations, edit checks, consistency checks, validations, procedures and rules and for writing data extraction programs
- Coordinates and ensures timeliness and quality for the development of study reporting and visualization environment which includes CRF and non-CRF (loaded) data in addition to transforming collected data to required reporting format.
- Performs peer review
- Accountable for the timeliness and quality of study level documentation for all databases used in data management
- Accountable for study database documentation maintenance in the electronic Trial Master File (eTMF)
- Works in collaboration with the GST to define all technical elements of the Data Management Plan
- Accountable for the timeliness and quality of system testing and Quality Control (QC) of specified deliverables
- May assist in maintaining the Clinical Data Management Systems global and program libraries
- May be required to undertake programming and testing tasks as needed
- Participates in projects to automate, simplify and innovate in order to ensure that the team is industry leading
- Mentor and train Database Developers
- Bachelor's degree, preferably in computing or scientific discipline
- 3 to 7 years database development experience in the pharmaceutical industry working with clinical trial data
- Clinical trial knowledge
- Experience with Medidata's Rave Study Build
- Experience in Medidata Rave Custom Functions
- Practical experience with object-oriented programming using .NET technologies, C#, Visual Basic, MS SQL, SAS, R, Python
- Excellent written and verbal communication skills, organized and ability to lead tasks from concept to delivery
- Excellent understanding of clinical data system design / development / validation and system interoperability.
- Ability to work independently without close supervision
- Excellent planning and project management skills.
- Ability to work in a global team environment
- Excellent organizational and analytical skills and high attention to detail
- Demonstrated 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, database development, data handling and reporting
- Demonstrated 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
- Experience or knowledge of Rave Safety Gateway, TSDV
- Experience with programming languages Python, APEX, PL SQL, XML, Java an advantage
- Experience with reporting environments Crystal Reports, Business Objects, Tibco SpotFire, PowerBI, Tableau