Clinical Trials Data Management Specialist

Experience in a central laboratory, CRO, sponsor data management, or clinical operations environment.

Exposure to 21 CFR Part 11, GCP, or GCDMP compliance requirements in a data or systems context.

Experience developing SDTM datasets for regulatory submission or sponsor delivery.

We know that health is more than doctor visits and life is more than work. We work hard at Arkana but in turn provide competitive salaries and generous benefit offerings.

Generous paid time off and Paid Holidays

Minimal cost health insurance for you and affordable options for your family

401(k) with immediate eligibility and match

Company-paid life insurance

The Clinical Data Programmer develops, validates, and maintains Python scripts used to extract, transform, and deliver clinical trial data to pharmaceutical sponsors in compliance with Data Transfer Agreements (DTAs), DB Specifications, and applicable regulatory standards including CDISC/SDTM.

The Programmer also supports complex EDC configuration tasks that require programming-level knowledge, including adjudication workflow logic and custom functions in Medidata Rave.

This role works closely with the Clinical Trials Data Specialist through paired work, code review, and day-to-day technical partnership.

Develop, maintain, and version-control Python scripts for data extraction, transformation, SDTM domain mapping, and production of sponsor-ready output files using Azure DevOps.

Validate all script output against DTA specifications, DB Specs, and SDTM/CDISC requirements before every production transfer; maintain script self-certification logic.

Execute test transfers and coordinate with the Data Management team on production release through the Azure DevOps pull request approval workflow.

At Arkana Laboratories, everyone has an important role to fill. Come join us and be a part of a team dedicated to making life better for those who need it most.

This place is packed with super-smart people who do their best work together. We work hard every day to advance our understanding of disease and provide world-class care to our patients in hopes of leaving our corner of the world a little better than we found it. While we are committed to improving the lives of thousands of patients, we never lose sight of the realization that they are the reason we get to create change in our field.

Built on generosity, teamwork, and the freedom to try new things, we take great pride in our work. Great ideas come from everywhere in this company and we celebrate each success and failure for the opportunity it gives us to keep reaching. For more than twenty years after our founder, Dr. Patrick Walker, wrote his goals on the back of a napkin, our people, culture, and values have remained strong.