Purpose:

The Clinical Supply Systems Owner non-GXP systems, Clinical Supply Management (CSM) is responsible for ownership of non-GXP CSM systems. This position will identify and resolve issues with existing systems within CSM                  

Responsibilities:

• Responsible for compliance with applicable Corporate and Divisional Policies and Procedures and implements System enhancements and deployment for non-GXP systems. Assist in requirement collection, meetings with SME's and workshops.
• Assist in updates of system related documentation including but not limited to SNOW, Diet Tickets, Demands and Initiatives and assists in the development of training materials and training of end users.
• Assist in updates of system related documentation including but not limited to SNOW, Diet Tickets, Demands and Initiatives.
• Business end user Support, how to use the system, day to day help, central “go to”-point for CSM system related matters and system communication.
• Master Data Management for CSM systems including Report metrics on error messages to reduce # of occurrences in the future and system configurations /maintenance of configuration spreadsheet.
• Assist in Implementation and development of reports both validated and non-validated including Data extracts (provide data from the database via SQL tools and send as excel).
• Training activities including performing system training for all new users and modify user accounts as needed, Offering Q& A Sessions for CSM systems, assist in SOP development, and maintain the business practices documentation.
• Shipment Tracking including performing quick ships, system receipt activities (for shipments that are not entered by the Third Party Distributors) and review open POR’s.
• Receives user management requests and routes through the established IT channels (generate IAM request) for Validated CSM systems, Setup and Maintain user accounts and access privileges for non-validated CSM systems including but not limited to PPSD, SSF, QAPL, and Support System re-certification performed by IT.
• Complete vendor system activities for manufacturing done at Third Party Manufacturer’s Print and provide blind breaker envelops for clinical trials.

Basic:

•Bachelor’s degree: Life or Physical Sciences preferred.
•At least 4 years experience in the pharmaceutical industry and knowledge of business systems.
•Working knowledge of the overall drug development or clinical development process, including knowledge of Clinical Supply Systems.