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Job Title: Manager Database Management & Analytics, CSPV

Hours: Must be available to work during US Business Hours

Type: Contract

Responsibilities:

+ Assists in the implementation of project specific safety database configurations to meet the regulatory and business needs of the CSPV department.

+ Participates in system validation activities for the safety database and other safety-related systems.

+ Perform quality checks on configuration changes performed by the database service provider; Identify discrepancies between the request and the implementation and resolve or initiate their resolution.

+ Serve as a system administrator and perform configurations/master data updates like 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 the configuration forms and coordinate with the Safety system service provider to complete the needed configurations.

+ Maintain best practices for safety database configurations, customizations, aggregate reporting, data migration, data integration, E2B Gateway reporting set-up, interface with EDC and other new automation initiatives.

+ Assists with data management of safety-related PV systems.

Requirements:

+ Experience supporting Oracle Argus Safety is required.

+ Experience in safety reporting applications is required.

+ Knowledge of PV reports would be helpful.

+ Relational database(Argus Safety database) knowledge working with Oracle and SQL is required.

+ General knowledge of Electronic Data Interchange (Axway B2Bi Interchange in particular a plus), Rave Safety Gateway, E2b Pilot Test with HA.

+ General knowledge about the global safety reporting requirements and ICH E2B guidelines that govern the international reporting of adverse events on investigational and marketed products are preferred.

System One, and its subsidiaries including Joulé, ALTA IT Services, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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Ref: #568-Clinical

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.