Note: The job is a remote job and is open to candidates in USA. Red Nucleus is seeking an Associate / Senior Associate, Clinical Data Management to support the delivery and oversight of clinical and patient-reported data in EDC platforms, including iTakeControl. The role supports studies from startup through closeout and collaborates with clinical operations, product, and technical teams.

Responsibilities

• Manage and review clinical and ePRO data, including video-based data collection
• Develop Data Management Plans, CRF Specifications, eCRFs, and study documentation
• Support data transfers, exports, migrations, and reconciliation activities
• Participate in site initiation visits, user acceptance testing (UAT), and product launches
• Collaborate with sponsors, sites, vendors, and cross-functional teams
• Support innovative approaches to remote data monitoring and patient-centric research

Skills

• Undergraduate degree or equivalent professional experience
• Experience supporting clinical study protocols, protocol amendments, observational research, registries, data migrations, reporting, and data transfers
• Professional experience within biopharma, pharmaceutical, CRO, clinical site, or consulting environments
• Knowledge of GCP, ICH, HIPAA, GDPR, FDA requirements, FDA 21 CFR Part 11, Annex 11, and GxP processes
• Experience with or understanding of EDC, ePRO, EHR, clinical research technologies, and health data collection systems
• Experience managing multiple projects, timelines, stakeholders, vendors, and study teams simultaneously
• Strong written and verbal communication skills with proficiency in Microsoft Office (Word, Excel, PowerPoint)
• Digital health, digital therapeutics, or mobile application experience
• Experience in rare diseases, gene therapy, or long-term follow-up studies
• Experience working with central or specialty laboratories/vendors
• Familiarity with CDISC, CDASH, SDTM, FHIR, OMOP, MedDRA, and WHO Drug standards and dictionaries

Company Overview

Company H1B Sponsorship