21 ago - Italia
Alira Health
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.
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.
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. 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.
Make recommendations for database setup process improvements and development of new standards.
Input into and monitor progress against study project plan and escalates issues to resolution at the appropriate level.
Prove ability to analyse data capture problems/opportunities and deliver high‑quality solutions.
Demonstrate broad and integrated knowledge of all aspects of Database Programming, providing consultancy to other groups outside DBP.
Educate/train on use of study‑specific data collection tool(s).
Represent Database Programming in in
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Humangest S. P. A.
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GiGroup
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as loft
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Adecco Italia