Clinical Trials Data Management Specialist

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.

What you'll do

• Data Transfer Scripting and Clinical Data Quality
• 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.
• 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.
• 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
• 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.

Required

• 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.

PREFERRED

• 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.

Education

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

What we offer

• Competitive salary
• 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
• 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
• Monthly in-office massages and employer-sponsored lunches