Clinical Trials Data Management Specialist

Arkana Laboratories•Little Rock, AR

20d•Onsite

About The Position

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. We're looking for a Clinical Trials Data Management Specialist who can turn approved Data Transfer Agreements, database specifications, CRFs, and protocols into clean, validated Python scripts, and who takes real ownership over transfer readiness and data quality along the way. You'll dig into test and production transfer files, catch discrepancies before they become problems, and keep documentation audit and inspection ready every step of the way. You'll also flex into EDC QC and build support, helping confirm that what's collected lines up cleanly with what needs to be delivered.

Requirements

1-2 years of experience in clinical data, EDC systems, data QC, data transfer support, scripting, or another regulated data environment.
Working proficiency with Python or a comparable scripting language for data extraction, transformation, validation, and output-file generation.
Strong attention to detail and experience reviewing data across CRFs, exports, listings, specifications, source requirements, and final transfer outputs.
Ability to document assumptions, validation evidence, issue resolution, change history, and production-readiness decisions clearly.

Nice To Haves

Experience with at least one clinical EDC platform, such as Medidata Rave, REDCap, Veeva Vault, Oracle Clinical, Inform, or a similar system.
Experience working with DTAs, database specifications, CRFs, data dictionaries, source-to-target mappings, or sponsor transfer requirements.
Experience with C#, Rave custom functions, edit check logic, or similar clinical system programming.
Hands-on Medidata Rave experience, especially Rave Architect, Designer, edit checks, UAT, or build-level support.
Familiarity with CDISC, CDASH, SDTM, controlled terminology, and sponsor-ready or regulatory-ready clinical datasets.
Experience with Git, Azure DevOps, or similar version-control tools and controlled release and change-tracking practices.

Responsibilities

Create, update, and validate Python-based scripts used for data extraction, transformation, QC checks, and sponsor-ready file generation.
Translate approved DTAs, database specifications, CRFs, protocols, scoring forms, and sponsor requirements into documented transfer logic and output rules.
Prepare and QC test and production transfer files using record counts, field-level checks, format checks, source-to-target review, reconciliation, and expected-value checks.
Review transfer requirements before scripting to identify required fields, mapping rules, visit naming, controlled terminology, date formatting, file structure, blinding considerations, and delivery dependencies.
Investigate transfer issues related to missing records, formatting problems, mapping gaps, value-range discrepancies, file structure, naming conventions, encoding, or sponsor feedback.
Perform QC of EDC builds, CRF configurations, edit checks, workflows, and data collection requirements against protocol and study-specific requirements.
Participate in study start-up scoping, UAT, amendment updates, and transfer-readiness discussions to help confirm EDC data collection aligns with downstream transfer needs.
Work closely with the CT Data & Project Lead and CT Data Specialist/EDC Builder to keep CRFs, raw exports, transformation logic, and sponsor deliverables aligned.
Participate in script review, peer review, and transfer-readiness discussions, and provide practical scripting guidance where appropriate.
QC data transfer or scripting-related tasks completed by team members and document findings, questions, and resolution steps.
Follow team documentation, validation, version-control, and change-tracking practices, including clear notes for script updates and releases.