Senior Principal Clinical Database Programmer

November 14

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Lexitas

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Litigation Support Services • Deposition Services • Court Reporting • Records Retrieval • Realtime Reporting

501 - 1000 employees

🤝 B2B

☁️ SaaS

💰 Debt Financing on 2016-09

Description

• Provides support to the Data Management Project Manager and other study team members. • Performs clinical database configuration / programming and database report development activities throughout the course of the study. • Responsible for timely, complete, and accurate database project deliverables within the data management scope of services • Develop draft study database using sponsor protocol and standards (if applicable) and existing Lexitas templates • Implement post-production changes necessitated by protocol amendments or program changes following database go-live based on documented post-production change documentation • Assist in the facilitation of database user acceptance testing • Assist in the facilitation of database validation • Oversee issuance of queries and review query responses • Interact with internal study team members on database development and maintenance activities • Participate in client team meetings (as needed) as a technical resource with respect to database development and maintenance activities • Program randomization schemes if applicable

Requirements

• Bachelor's degree or equivalent combination of education and experience. • Master's degree preferred • 4+ years of hands-on clinical database programming/configuration experience, preferably in a CRO setting • Knowledge of Good Clinical Practices (GCP) and Good Clinical Data Management Practices (GCDMP) • Relevant clinical database development experience inclusive of technical experience within and outside of Data Management • Experience with one or more commercial EDC platforms (Merative Zelta, IBM Clinical Development, Medrio, MedNet, Medidata RAVE, Datatrak). • Experience in IBM Clinical Development is preferred • Competent computer skills including MS Office Suite • Experience with SAS a plus • Experience with SQL a plus • Experience with CDISC data standards a plus