Clinical Data Management Associate | Impactful, Patient-Centered Data

Red Nucleus; Yardley (Bucks County); On-site; USD 85,000 - 125,000; Full time

Job summary

Red Nucleus seeks an Associate/Senior Associate, Clinical Data Management to support data quality and patient-centered research across studies in EDC platforms, including the iTakeControl (iTC) technology. You will work with clinical operations, product, and technical teams from startup through closeout.

The role requires 0–10 years of experience in biopharma/CRO environments, with strong knowledge of GCP/ICH, HIPAA, GDPR, and FDA regulations, and proficiency in EDC, ePRO, and EHR systems.

Qualifications

• Bachelor's degree or equivalent professional experience
• Experience supporting clinical study protocols, amendments, observational research, registries, data migrations, reporting and data transfers
• Experience in biopharma, CRO, clinical site, or consulting environments
• Knowledge of GxP, FDA 21 CFR Part 11, Annex 11, and GDPR/HIPAA
• Experience with EDC, ePRO, EHR, and health data collection systems
• Experience managing multiple projects, timelines, stakeholders, vendors, and study teams
• Strong written and verbal communication with MS Office proficiency

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 reconciliations
• Participate in site initiation visits, UAT, and product launches
• Collaborate with sponsors, sites, vendors, and cross-functional teams
• Support remote data monitoring and patient-centric research approaches

Skills

GCP/ICH knowledge

Data management

Project management

Communication skills

EDC familiarity

Education

Undergraduate degree or equivalent

Tools

iTakeControl (iTC) platform

MS Office

EDC systems

Job description

Red Nucleus seeks an Associate/Senior Associate, Clinical Data Management to support data quality and patient-centered research across studies in EDC platforms, including the iTakeControl (iTC) technology. You will work with clinical operations, product, and technical teams from startup through closeout.

The role requires 0–10 years of experience in biopharma/CRO environments, with strong knowledge of GCP/ICH, HIPAA, GDPR, and FDA regulations, and proficiency in EDC, ePRO, and EHR systems.