Data Management Programmer - 897325 UR
3 days left
- Experience Level
- Experienced (non-manager)
Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, committed into delivering products on the market over the next 5 years, is looking a Data Management Programmer for a Permanent position to be based in Basel area.
The ideal candidate should have 5 years of previous experience in programming of which at least one in a data management function of a pharmaceutical company or a clinical research organization
- Support remote patient data monitoring workflows and data processing: work on processes, software, and infrastructure to handle data collected
- Develop review tools for patient data monitoring and provide regular outputs to clients as per Central Clinical Monitoring Plan
- Develop Database: design, create, maintain and close project and trial capture databases using paper and EDC systems
- Develop and maintain data standards (CDISC), manage ad hoc and standard reporting, develop and maintain internal documentation.
- Program data extractions, data listings for data cleaning purposes, logical checks, protocol violations, according to specifications provided by the TRIAL DATA MANAGER and in line with the quality standards
- Implement, execute, schedule procedures to manage CRF and non-CRF data
- Test the clinical databases and validation procedures
- Keep track of data management status activities on different studies
- Contribute to developing and implementing new technologies
- Assist in programming activities for Regulatory Submission (FDA filing) and Audit Requirements.
Qualifications and Experience:
- Relevant working/residency permit or Swiss/EU-Citizenship required.
- University degree (or equivalent) in mathematics, informatics, engineering or related disciplines or high school qualification
- At least 3-5 years’ experience in programming of which at least one in a data management function of a pharmaceutical company or a clinical research organization
- Good knowledge of programming languages and knowledge of data management principles and tools
- Experience with CTMS and understanding of LAB and other third-party data
- Experience and understanding of CDISC/SDTM standards
- Experience with Clinical Data Management System, including:
- EDC Database build, Validations/Derivations, Coding, Discrepancy Database/Querying
- Standardization modules, data reporting tools
- Develop/maintain global data standards, CDISC/STDM mapping
with expertise knowledge of at least one area mentioned above
- Good Knowledge of international clinical research regulations and requirements (e.g. ICH/GCP) and 21 CFR Part 11Experience in maintaining and supporting data management and biostatistics processes in a distributed client base within a regulated environment
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