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