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Ecocareers · 1 month ago

Clinical Database Programmer

United States

Full-time

Remote

Mid Level

4+ years exp

Ecocareers is a company focused on clinical data management, and they are seeking a Clinical Database Programmer to join their Data Sciences group. The role involves SDTM programming, the development and maintenance of SDTM datasets for clinical studies, and utilizing elluminate for data visualization and review.

Staffing & Recruiting

Responsibilities

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

Develop at least a subset of SDTM datasets within elluminate

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

Duties, responsibilities, and activities may change, or new ones may be assigned as business and organizational requirements evolve

Qualification

SDTM programmingSAS programmingSQL programmingElluminate experienceCDISC knowledgeMedical coding knowledgeWillingness to learnTeam playerCommunication skills