Associate, Clinical Data Management (RID00216)

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

Associate / Senior Associate, Clinical Data Management

Clinical Research | Red Nucleus

Are you passionate about clinical data quality and the future of patient-centered research?

We're looking for an Associate / Senior Associate, Clinical Data Management to support the delivery and oversight of clinical and patient-reported data within EDC platforms, including our innovative iTakeControl (iTC) technology. You'll work across clinical operations, product, and technical teams while supporting studies from startup through closeout.

Experience Level: 0-10 years

Required Qualifications

• 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)

What You'll Do

• 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

Nice to Have

• 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

Diversity, equity and inclusion are valued at Red Nucleus and we believe we have a shared responsibility to provide equal opportunity and foster an inclusive spirit. We do not discriminate on the basis of race, color, national origin, religion, caste, sexual orientation, gender, age, marital status, veteran status, or disability status.

To learn more about working at Red Nucleus, please visit Careers | Red Nucleus.

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