The Senior Clinical Database Analyst - I is the expert and responsible for developing and implementing database elements (structure, data entry screens, edit checks) and he/she is also responsible for setup of peripheral tools of clinical database collection system. He/she ensures that any study databases are set up according to defined timelines. He/she manages the study databases in compliance with the worldwide clinical standards to support a flawless conduct of clinical trials. He/She is the expert for Clinical study database, support and maintenance activities.
MAJOR DUTIES & RESPONSIBILITIES
(what the job does)
- Responsible for developing/update study setup Gantt Chart to comply with study timeline, and followup the data management related tasks implementation per Gantt.
- Responsible for implementing studies in current clinical data management systems.
- Responsible for programming study Edit Check (EC) and QC.- Responsible for the CDMS peripheral tools setup for example SAGA, EDL.
- Responsible for the database modification and maintenance during study conduction phase.
- Responsible to commit realistic time schedules for database set up delivery
Responsible for clinical database administration (creation, modification, distribution, lock).
Expert contact for Study Data Managers (SDMs) or CTOM (Clinical Trial Operation Manager) concerning database support activities; proposes solutions for data management issues that arise during study conduct.
- Expert contact for new technical solutions (associated with clinical data management systems) implementation and processes in interaction with the appropriate working groups.
- User testing of relevant software patches/upgrades
Interacts closely as an expert in database design with CRF Designer
Request new database models or updates to the DB Implementation Manager for validation
Serve as an expert for coaching new DBD in the areas of standards, database administration, design and programming
Within database design, standards group, continually evaluates processes and applications for improvements, as well contributes to improvements within CDM generally.
Participates in the implementation of department initiatives (e.g. new tools, new standards, process improvements).
Participates in working groups to develop and implement new applications and procedures.
Maintains knowledge of current regulations and technologies related to the data management function. Deputizes for the Standard Implementation Head, Study Implementation Manager, when appropriate.
JOB-HOLDER ENTRY REQUIREMENTS:
Bachelor degree, preferably in a life science or mathematics-related area (e.g., computer science or similar technical field).
At least 3 years experience in clinical database design and maintenance are required and he/she can lead database design for phase II/III trails with minium coach of manager. In addition, clinical trial experience, clinical data management experience and pharmaceutical industry experience are preferred.
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