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Associate, Clinical Data Management (RID00216)

Red Nucleus
Yardley, USA
Full-time
Entry · 0–10 years experience
Onsite
Discovered 2 days ago
gcp

Full Job Posting

Experience

  • Level: 0-10 years
  • 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

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.
  • #LI-KS1

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