ProClinical is currently seeking a Clinical Data Programmer for a global pharmaceutical company, leaders in the science and medicine of pulmonary arterial hypertension (PAH), with over 15 years of experience in this devastating cardiovascular disorder. This Clinical Data Programmer role is a contract position, based in Basel Switzerland.
- Develop and maintain Clinical Database (Medidata RAVE EDC system)
- Program and ensure the quality of validation and derivation procedures
- Program data extractions, data listings for data cleaning
- Develop and maintain data standards (CDISC), manage ad hoc and standard reporting, develop and maintain internal documentation
- Keep track of data management status activities on different studies
- Identify areas and suggest solutions for process improvement
- Assist in developing and implementing new technologies
- Assist in programming activities for Regulatory Submission (FDA filing) and Audit Requirements.
Skills and Requirements:
- University degree (or equivalent) in mathematics, informatics, engineering or related disciplines or high school qualification
- At least 3 years’ experience in programming 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 CDMS and understanding of LAB and other third-party data
- Proficient programming skills in Medidata RAVE environment
- Knowledge and experience using C# Programming for RAVE custom function
- Experience and understanding of CDISC standards
- Experience with Clinical Data Management System, including: Standard Library, Architect, Edit Checks; Database build, Validations/Derivations, Coding, Discrepancy Database/Querying; Standardization modules, data reporting tools; Develop/maintain global data standards
- Knowledge of international clinical research regulations and requirements (e.g. ICH/GCP) and 21 CFR Part 11
- Sound knowledge of clinical trial process
- Experience in maintaining and supporting data management and biostatistics processes in a distributed client base within a regulated environment
- Fluent in written and spoken English
- Proficient in Microsoft Windows and Office
- Knowledge/experience in following areas will be considered as a strong additional asset: SAS Programming; STDM Mapping; eCRF Design Process.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Sam Walker on +44 203 8569 336 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.