Clinical System Manager
- Experience Level
- Experienced (non-manager)
Our client, a dynamic global bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, is looking for a System Manager on a 6+ month contract based in the Basel area.
The ideal candidate should have minimum 3-7 years of experience in System mangement and will lead project for new system releases on behalf of the business((Medidata RAVE, CTMS and eTMF ).
- Contribute to business administrators and system administrator appointment;
- Supervise business administrators and system administrators or document delegation of supervision;
- Single point of contact for system deliverables;
- Lead project or operational risks identification and prepare risk mitigation tactics;
- Lead new system releases or project on behalf of the business;
- Lead system concept of operations and operating plan including system budgeting and resource allocation to buy, develop, deploy, operate and maintain the system.
Qualifications and Experience:
- Knowledge and experience in supporting : Medidata RAVE, CTMS and eTMF;
- Knoweldge of computer system validation and code of Federal Regulations (CFR) 21 Part 11 and required documentation;
- Good understanding of drug development and business processes in GCD;
- Good understanding of the Good automated manufacturing practice (GAMP)5 software development cycle;
- Knowledge and experience in system lifecycle management in a GxP environment and system validation;
- Excellent written and oral communication skills in English;
- Relevant working/residency permit or Swiss/EU-Citizenship required.