Job Description
This role will provide the support and maintenance of our primary clinical data acquisition system ACQUIRE CLINICAL, which is a suite of Medidata 15 products incl. iMedidata, Rave, Coder under the responsibility of us. This system will need to be elevated to use Cloud Admin and Coder+.
This role will provide the support and maintenance of Our Trial Grid system, which is used to check clinical study builds for ACQUIRE CLINICAL.
Medidata constantly releases new versions of its products, which need to be assessed for impact in terms of availability, maintenance, security, or interfaces. If necessary, an IT change needs to be performed, which includes changing computerized system validation documentation and IQ (and OQ) testing. Changes may also need to be performed when user requirements change or are added. This role will drive the changes. Some changes may have to be driven as projects due to their size, which include performing typical project management activities.
Access management for some user roles of ACQUIRE CLINICAL needs to be done (granted, revoked).
TrialGrid constantly releases new versions of its product, which need to be assessed for impact in terms of availability, maintenance, security, or interfaces.
Also, incidents, which occasionally occur, must be driven to solution in collaboration with the respective subject matter experts at Medidata or Us.
Also, the periodic review of the ACQUIRE CLINICAL and TrialGrid systems needs to be supported.
Requirements
Education
• Bachelor (at minimum) in computer sciences or similar
Experience
• experience with Medidata products is a must (e.g. iMedidata, Cloud Admin, Rave, Coder)
• experience with computerized system validation is a must
• experience with computerized system testing is a must
• experience with IT change management is a must
• experience with access management is a must
• experience with project management
• experience with incident management (ITIL) is preferred
• experience with TrialGrid preferred
• 3 or more years in pharma industry is preferred
• experience with Clinical Development is a plus
Soft skills
• Being fluid in English is a must• Must be able to write technical documentation
• Must be able to work well in a team