Business System Analyst – Clinical and Quality Systems

Basel Area
13 Dec 2018
26 Feb 2019
Contract Type

Main Responsibilities:

  • Assessment of user needs through close cooperation with business functions to provide support and proactive service, including analysis of opportunities in accordance to the IT strategy and architecture;
  • Focal point to communicate system related problems, in collaboration with the IT teams and the software vendor on changes, fixes, and updates;
  • Ongoing troubleshooting, user support, and maintenance of systems and ensure customer satisfaction;
  • Support for system release process including vendor management, coordination of validation activities with development and execution of testing, and end user communication;
  • Development of training documentation and eLearning modules, and coordination or provision of end user training;
  • Creation of system related QS documentation (SOPs, WISs, etc.) in compliance with relevant policies and standards;
  • Guarantee compliance to CSV requirements, IT Policies, and standards;
  • Configuration of new functionalities based on user requirements;
  • Good understanding of business requirements and technology to support business objectives;
  • Project management for selected business initiatives.

Qualifications and Experience:

  • University degree in science, computer science, management information systems, or related field;
  • Approximately five years of professional experience, preferably minimum three years in the pharmaceutical industry;
  • Three or more years of experience in business area in support and managing relevant IT systems, e.g. electronic Document Management System (EDMS), Quality Management System (QMS), electronic Trial Master File Systems (eTMF), Clinical Trial Management System (CTMS), Electronic Data Capture (EDC);
  • Experience in drug development and clinical operations;
  • Experience in development of training documentation and eLearning Modules and providing end user training;
  • Strong knowledge in system management and administration, Veeva Vault end user or administrator experience is beneficial;
  • Experience with managing software as a service (SaaS);
  • Strong knowledge of Computer System Validation and Code of Federal Regulations CFR 21 Part 11 and required documentation;
  • Good understanding of GAMP5 software development and ITIL framework, certification is an asset;
  • Very good knowledge of regulated environments (GxP, preferably GLP or GMP)
  • Experience with QMS processes (e.g. CAPA management, deviation management, change management) is beneficial;
  • Strong communication skills, able to understand problems and present solutions towards business partners;
  • Good analytical skills, and ability to understand business requirements, and transform into IT solutions;
  • Independent, and hands-on working style, team player, highly self-motivated, autonomous, proactive and change oriented;
  • Fluent in English (written and spoken), French and/or German is a plus;
  • Relevant working/residency permit or Swiss/EU-Citizenship required.

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