Business System Anaylst - Clinical & Quality Systems
Posted on Feb 26, 2020 by Experis AG
Quality Systems Analyst - Clinical experience
Experis IT is Europe's leading IT recruitment agency. We are dedicated to connecting talented individuals with Business opportunities across a number of professional sectors, with IT being at the heart of our operations.
For one of our fast-growing international clients, specialized in the discovery and development of small molecules, we are looking for a Business Systems Analyst with strong experience in Clinical & Quality Systems.
The Business Systems Analyst is responsible for management and support of business systems. This includes the implementation, integration, testing and management of system releases, as well as end user support with a strong understanding of the pharmaceutical regulations.
Tasks & 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
- Ongoing troubleshooting, user support, and maintenance of systems and ensure customer satisfaction
- Drive 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
- Creation of system related quality documentation (SOPs, WISs, etc.) in compliance with relevant policies and standards
- Guarantee compliance to CSV requirements
- Configuration of new functionalities based on user requirements
- System Administrator for Veeva Vault
- Master's degree in computer science, system analysis or a related study, or equivalent experience
- Minimum of 5 years' experience in the pharmaceutical industry with experience in drug development and clinical operations
- Minimum 5+ years' experience in supporting and managing IT systems, eg electronic Document Management System (EDMS), Content Management System (CMS), electronic Trial Master File Systems (eTMF)
- Experience in Veeva Vault administration and configuration
- Experience in development of training documentation and eLearning Modules and providing end user training
- Strong knowledge in system management and administration
- 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
- Hands-on experience with managing software as a service (SaaS)
- Excellent analytical skills
- Motivation that is focused on long-term results
- Strong written and verbal communication skills in English
Location: Basel Area
Start Date: ASAP
If you are a result-oriented Business System Analyst currently looking for a challenging new position that applies to your skills, then we look forward to receiving your application!