Associate, Clinical Data Management (RID00216)

Red Nucleus • Yardley, PA

2d

About The Position

Red Nucleus is seeking an Associate / Senior Associate, Clinical Data Management to support the delivery and oversight of clinical and patient-reported data within EDC platforms, including its iTakeControl (iTC) technology. The role works across clinical operations, product, and technical teams and supports studies from startup through closeout. The stated experience level is 0–10 years.

Requirements

• 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 and proficiency in Microsoft Office (Word, Excel, PowerPoint).

Nice To Haves

• 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.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level