Clinical System Manager

Canton of Basel-Stadt (CH)
19 Jul 2019
18 Aug 2019
Full Time
Contract Type
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 ).

Main Responsibilities:

  • 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.