Job Description:
Support the system lead in the following tasks:
Project Manager and Communication lead for Source Clear (GxP validated system):
o Coordinate and collaborate with relevant functional teams to ensure sustainability and enhancement of the system:
Core Team IT/Support/Business process owner
Validation
Veeva Customer Success Manager
Focus group
All Country Leads
IT services transition
o Preparation of presentations Communications and Executive Summaries disseminated to Country Leads/Business Admins/Librarians (all affiliates)
o Maintain Source clear business governance guidance and other key documentation such as Access Management Associated Instructions Training Matrix training content. Proactively identify any needs for updates as well as informing the Source clear community and posting Newsflash and Tip s on the Clearance collaboration site
o Participate in content roadmap activities for technologies improvement
Source Clear Change Request Manager which includes the following activities:
o Manage Source Clear Change Requests (CRQ) release activities (4 to 5 per year):
Investigate Collect and keep up to date CRQ list and investigations
Build CRQ release planning & tasks (release cycle of 8 weeks) in accordance with GxP validated procedure
Update documentation in source Controlled docs (URS TMX )
Manage business PQs (Protocol Qualifications) in QALM system
Organize system testing as per validation requirements
Release communication to users
o Veeva release activities
Analyze the autoon enhancements versus configurable changes and their impacts
Update controlled documentation: Functional Risk Assessment (FRA)
Elaborate validate with core team and finally release communication to users
Be fully familiar with process practical guidance and system training for clearance of product/disease promotional/educational/press material and comply with GCC SOP 008512 and validation requirements
Support GCC with audits and inspections as required
Requirements
Experience with Veeva Vault PromoMats configurations updates system enhancements
Knowledge of GxP
Project management experience