Clinical Database Programmer

Essential Functions

• Annotate CRFs in accordance with CDISC published or program specific guidelines
• Craft SDTM dataset specifications
• Program and validate SDTM datasets in SAS and/or elluminate
• Participate in the quality assurance of vendor developed SDTM datasets and documentation
• Participate in the review of eCRFs and collection tools
• Participate in the review of data transfer specifications as it relates to data flow for the study
• Liaise with study team members and develop custom objects in elluminate
• Utilize the Mapper module and T-SQL programming to develop custom datasets
• Ensure documentation and validation of objects are timely and complete
• Participate in the testing of elluminate upgrades and documenting test scripts
• Ensures data standardization and maintains Ironwood data model across studies
• Contributes to quality system requirements for clinical data programming (e.g., review and/or develop SOPs)
• Promotes enduring relationships regarding datasets and data transfers with study team members, CROs, third party data vendors, and EDC vendors
• Maintains current knowledge of and ensures all functional work team activities are conducted in compliance with the full range of related internal and external systems, technology, regulatory, GxP requirements and related policies and procedures
• Advocates for full legal compliance and ethical conduct in all business transactions

Requirements

• 4+ years of experience in SDTM programming
• Experience with elluminate or a dynamic visualization tool
• Proven SQL & SAS programming experience
• Strong knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodologies
• Experience with CDISC® related data models like SDTM, and ADAM
• Knowledge of medical coding dictionaries (WHODrug, MedDRA)
• Ability and willingness to learn new technologies
• Excellent team player with strong verbal and written communication skills