Purpose and Scope
The Clinical Data Enablement (CDE) Database Build Lead will perform the creation and maintenance of clinical databases for Phase I-IV clinical trials executed by Astellas. An example of a clinical database would include an electronic data collection system (EDC) but could also include other data collection or review systems as appropriate.
Responsibilities and Accountabilities
- ✓Performs initial clinical database builds and associated updates per agreed upon requirements and established timelines
- ✓Contributes to related technical and/or process improvement initiatives associated with database builds and related efforts
- ✓Collaborates with any vendors providing programming support for clinical database development, as appropriate
- ✓Collaborates cross functionally to address any issues with the delivery or quality of supported clinical databases
Required Qualifications
- ✓BS or MS degree, preferably in Computer Science, Informatics/Data Science, or life science discipline
- ✓Prior pharma or CRO industry experience working on global clinical studies and projects or global process and system initiatives
- ✓Prior experience in clinical database programming or related role
- ✓Strong verbal and written communication skills
- ✓Demonstrated experience collaborating with others to achieve an objective
- ✓Familiarity with all phases of clinical development
Preferred Qualifications
- ✓Technical competency with programming languages (i.e. R, Python, SAS, SQL, etc…) used to support clinical trial data flows, reporting, analysis and/or data sharing
- ✓Demonstrated ability and experience contributing to global process or system improvement projects
- ✓Knowledge of data standards in industry (CDISC, CDASH)