Associate / Senior Associate, Clinical Data Management
Clinical Research | SS&A
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.