Job Description
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)
Job Details
| Role Level: | Mid-Level | Work Type: | Full-Time |
|---|---|---|---|
| Country: | India | City: | Bangalore North ,Karnataka |
| Company Website: | http://www.astellas.com/ | Job Function: | Information Technology (IT) |
| Company Industry/ Sector: |
Pharmaceutical Manufacturing | ||
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