Principal Database Programmer

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Responsibilities
- Accountable for driving achievement of project milestones from study start‑up through to delivery of the database and monitoring of time spent on tasks.
- Provide Database Programming input into protocol data collection assessments.
- Create the annotated CRF (aCRF) using company standards or Sponsor’s naming conventions in accordance with relevant company procedures.
- Accountable for building the clinical database, creating variables, codelists, forms and visits in accordance with the aCRF.
- Develop the computerized checks in accordance with the Data Validation Plan.
- Develop SAS checks in accordance with the Data Validation Plan.
- Implement mid‑study changes to the production eCRF when requested by the Lead DM.
- Communicate the database setup status and the achievement of milestones to the Lead DM.
- Create and validate import programs of electronic data received from external vendors.
- Import electronic data received from external vendors during the course of the clinical study.
- Program and validate data listings (e.g., Manual checks,



Medical Review listings, Coding report, etc.).
- Program and validate tracking or metric reports.
- Plan and prioritise work and take appropriate actions (e.g., escalation).
- Contribute in formal training for new database programming staff.
- Apply SOPs and guidance documents as well as applicable industry standards such as ICH, GCP, etc. to day‑to‑day activities and generate all required documentation for study files.
- Lead the DBP team, coordinate other DBP staff, provide direction regarding work assignment, scheduling and prioritizing, and monitor progress of activities.
- Maintain continuous and appropriate communication with Lead DM and/or study Project Manager and share critical and general issues.
- Develop and maintain a network of contacts within the study team.
- Make recommendations for database setup process improvements and development of new standards.
- Input into and monitor progress agai

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7ehxjs