Mgr, Database Management Systems

Key Responsibilities

• Lead development and maintenance of global clinical data standards, including CDISC-compliant operational data mappings and SDTM standards.
• Build and maintain Medidata Rave global library objects, including eCRFs, edit checks, and CRF Completion Guidelines.
• Develop SAS programs for edit checks, data imports, listings, custom reports, and clinical data validation.
• Create and manage clinical datasets from raw data using Base SAS, Advanced SAS, Macros, PROC SQL, and SAS ODS.
• Support CRF design, annotated CRFs, data mapping specifications, and define.xml requirements.
• Collaborate with Clinical Data Management, Clinical Operations, EDC Programming, vendors, and CRO partners to ensure consistent standards implementation.
• Drive process improvements, support governance committees, and provide mentorship to junior team members.
• Ensure compliance with CDISC standards, GCP, ICH guidelines, and regulatory requirements.

Required Qualifications

• Strong clinical domain knowledge with a solid understanding of clinical trial phases.
• Prior work experience must be within the clinical research, pharmaceutical, biotechnology, healthcare, or CRO industry.
• Hands-on experience programming Edit Check Listings using SAS.
• Experience with Data Import Programming using SAS.
• Experience utilizing SAS Output Delivery System (ODS) to generate reports in RTF, PDF, and HTML formats.
• Experience reading raw data files, creating data structures, handling missing values, troubleshooting programming errors, and managing clinical data.
• Experience appending and concatenating SAS datasets.
• Proficiency developing reports using PROC PRINT, PROC FREQ, PROC MEANS, PROC TRANSPOSE, and PROC SQL.
• Strong programming experience with SAS Macros and SQL.
• Experience creating SAS datasets from raw clinical data, including status and efficacy datasets.
• Able to develop project-specific macros and formats, load client data from external platforms, and prepare datasets for client delivery.
• Experience creating clinical listings and custom reports based on business requirements.
• Knowledge of Vendor Import Programming.
• Strong technical expertise in Base SAS, Advanced SAS, SAS Macros, SAS SQL, and SAS Grid.
• Able to develop code using Base SAS programs, SAS procedures, and standardized macros.
• Excellent written and verbal communication skills.

Preferred Qualifications

• Experience with CDASH and ADaM standards.
• Extensive Medidata Rave global library development experience.
• Knowledge of MedDRA, WHODrug, annotated CRFs, and data mapping specifications.
• Experience with Veeva, Medrio, Oracle Clinical, TrialGrid, or similar EDC systems.
• Demonstrated ability to lead cross-functional initiatives in a global clinical development environment.