Katalyst CRO · 1 month ago
Clinical Database Programmer
United States
Contract
Remote
Mid Level
4+ years expKatalyst Healthcares & Life Sciences is seeking a Clinical Database Programmer to join their Data Sciences group. This role focuses on SDTM programming and custom programming in elluminate, responsible for the development and maintenance of SDTM datasets across clinical studies while ensuring compliance with data standards and quality assurance.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
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
Required
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
Associate's degree or higher in information systems, science or related discipline
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
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Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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