Arkana Laboratories

Arkana Laboratories

Clinical Trials Data Management Specialist

Arkansas · Full-time

Sponsorship not specifiedDetected 7 days ago
PythonC#Code ReviewGitAzureDevOpsClinical Trials

About the role

  • 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.

Responsibilities

  • Create, update, and validate Python-based scripts used for data extraction, transformation, QC checks, and sponsor-ready file generation.
  • EDC QC, UAT, and Build Support
  • Perform QC of EDC builds, CRF configurations, edit checks, workflows, and data collection requirements against protocol and study-specific requirements.
  • 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.
  • QC data transfer or scripting-related tasks completed by team members and document findings, questions, and resolution steps.
  • Ability to document assumptions, validation evidence, issue resolution, change history, and production-readiness decisions clearly.
  • Hands-on Medidata Rave experience, especially Rave Architect, Designer, edit checks, UAT, or build-level support.

Requirements

  • Review transfer requirements before scripting to identify required fields, mapping rules, visit naming, controlled terminology, date formatting, file structure, blinding considerations, and delivery dependencies.
  • 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.
  • Experience with at least one clinical EDC platform, such as Medidata Rave, REDCap, Veeva Vault, Oracle Clinical, Inform, or a similar system.
  • Experience with C#, Rave custom functions, edit check logic, or similar clinical system programming.
  • Experience with Git, Azure DevOps, or similar version-control tools and controlled release and change-tracking practices.

Nice to have

  • Bachelor's degree preferred.
  • Equivalent directly related experience may be considered in lieu of a degree.

Compensation

  • Competitive salary

Benefits

  • 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.
  • Specifically, we offer the following benefits to full-time employees:
  • Generous paid time off and Paid Holidays
  • Minimal cost health insurance for you and affordable options for your family
  • Company-paid life insurance
  • Company-paid long term disability coverage
  • Affordable vision and dental plans
  • Flexible Spending Account or Health Savings Account availability
  • Wellness plan and complimentary yoga classes

Company info

  • 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.
  • Position Summary: 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.
  • 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.
  • Position Summary: 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 also flex into EDC QC and build support, helping confirm that what's collected lines up cleanly with what needs to be delivered.
  • Data Transfer Scripting and Clinical Data Quality
  • 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.
  • Investigate transfer issues related to missing records, formatting problems, mapping gaps, value-range discrepancies, file structure, naming conventions, encoding, or sponsor feedback.
  • Participate in study start-up scoping, UAT, amendment updates, and transfer-readiness discussions to help confirm EDC data collection aligns with downstream transfer needs.
  • Clinical Trials Team Partnership
  • Participate in script review, peer review, and transfer-readiness discussions, and provide practical scripting guidance where appropriate.
  • Follow team documentation, validation, version-control, and change-tracking practices, including clear notes for script updates and releases.

Visa & Work Authorization

  • Create, update, and validate Python-based scripts used for data extraction, transformation, QC checks, and sponsor-ready file generation
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