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

QualificationsRequired 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

- Solid 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)

📌 Database Programming Manager (Karnataka)
🏢 Astellas Pharma
📍 Karnataka