Manager Database Management & Analytics, CSPV

Manager Database Management & Analytics, CSPV Overview

Local candidate preferred; office 1 day a week. Travel expenses absorbed by candidate.

Work during US business hours.

• Assist in implementing project specific safety database configurations to meet regulatory and business needs.
• Participate in system validation activities for safety database and other safety-related systems.
• Perform quality checks on configuration changes performed by the database service provider; identify discrepancies and resolve or initiate resolution.
• Serve as system administrator and perform configurations/master data updates such as code lists, user access, reporting rules, product and study pilot tests with E2b partners in development environment.
• Work with CSPV team(s) and DBMA team to complete configuration forms and coordinate with safety system service provider.
• Maintain best practices for safety database configurations, customizations, aggregate reporting, data migration, data integration, E2B Gateway reporting set-up, and interfaces with EDC and other new automation initiatives.
• Assist with data management of safety-related PV systems.
• Other duties as assigned.

• Experience supporting Oracle Argus Safety required.
• Experience in safety reporting applications required.
• Knowledge of PV reports useful.
• Relational database (Argus Safety database) knowledge; working with Oracle and SQL required.
• General knowledge of electronic data interchange (Axway B2
  
  Bi interchange in particular), Rave Safety Gateway, and E2B pilot test with HA.
• General knowledge of global safety reporting requirements and ICH E2B guidelines preferred.

• Professional, respectful, proactive demeanor.
• Effective communication and collaboration with stakeholders and functional areas.
• Willing and able to provide support to other team members on projects, tasks, etc.