[成都]赛诺菲（中国）投资有限公司上海分公司

职能类别:大学/大专应届毕业生

KNOWLEDGE AND SKILL REQUIREMENTS

Technical knowledges

Expertise in Clinical Data Management Systems (e.g. Medidata Rave) and in the use of Data Management applications and database/file structures

Expertise in database administration, design/programming, query language and metadata validation

Knowledge of industry standards and practices (e.g. CDISC/CDASH)

Custom function programming ability by using C#

Problem solving & Decision making 

Anticipate complex problems and proactively works to minimize the impact. Delivers on commitments with high quality results.

Ability to analyze issues (i.e. context, impact risk)

Ability to make decisions when needed and take responsibility (accept accountability for results,  even if the outcomes are difficult or sensitive)

Oversight & Coordination

Ability for performing quality controls and ensuring maintenance on databases

Strong organizational skills and ability to handle multiple tasks, paying attention to details and defining priorities.

RANK MAJOR DUTIES & RESPONSIBILITIES 

1. - Responsible for implementing standards and studies in current clinical data management systems.

    - Responsible to commit realistic time schedules for database set up delivery

    - Responsible for clinical database administration (creation, modification, distribution, lock). - All standards and studies are implemented acccording to Sanofi SOPs, processes and standards to ensure high quality of data management

2.   Expert contact for Data Managers (DMs) or CTOM (Clinical Trial Operation Manager) concerning database support activities; proposes solutions for data management issues that arise during study conduct. All databases are compliant with the level of quality required by ICH/GCP in order to deliver reliable and accurate data computerized for statistical analysis

3.   Request new database models or updates to the CIG (Clinical Information Governance) team for validation Continous improvement of database standards implementation

4. - 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

JOB-HOLDER ENTRY REQUIREMENTS:

Education:

Bachelor degree, preferably in a life science (e.g., clinical medicine or pharmacy) or mathematics-related area (e.g., computer science or similar technical field).

Experience:

At least 1 year experience in clinical database design and maintenance are required. In addition, clinical trial experience, clinical data management experience and pharmaceutical industry experience are preferred. 

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