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Associate, Clinical Data Management
Red Nucleus. Manage and review clinical and ePRO data, including video-based data collection .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing clinical and ePRO data, developing data management plans, and supporting clinical study protocols while ensuring compliance with GCP, ICH, HIPAA, and FDA regulations. Proficient in collaborating with cross-functional teams and managing multiple projects within biopharma and clinical research environments.
Highest-signal resume keywords
Clinical Data ManagementEPRO ExperienceGCP KnowledgeEDC Platforms ProficiencyProject Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Data Management PlansCRF SpecificationsECRFs DevelopmentData TransfersData ReconciliationClinical Study ProtocolsHealth Data Collection SystemsMicrosoft OfficeClinical Research TechnologiesRegulatory Compliance
Soft Skills
Strong Communication SkillsCollaborationProblem-Solving
Tools & Technologies
ITakeControl (iTC)EDC PlatformsClinical Research Technologies
Industry Keywords
BiopharmaPharmaceuticalCROClinical SiteDigital HealthGene TherapyRare DiseasesCDISCFDA 21 CFR Part 11GxP Processes
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- 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
- Support delivery and oversight of clinical and patient-reported data within EDC platforms, including iTakeControl (iTC) technology
- Support studies from startup through closeout
Requirements
What you’ll need- 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
- Proficiency in Microsoft Office (Word, Excel, PowerPoint)
- Experience level of 0–10 years stated
- Nice to have: digital health, digital therapeutics, or mobile application experience
- Nice to have: experience in rare diseases, gene therapy, or long-term follow-up studies
- Nice to have: experience working with central or specialty laboratories/vendors
- Nice to have: familiarity with CDISC, CDASH, SDTM, FHIR, OMOP, MedDRA, and WHO Drug standards and dictionaries
Benefits
Comp & perks- Equal opportunity and inclusive workplace commitment
- Non-discrimination on the basis of race, color, national origin, religion, caste, sexual orientation, gender, age, marital status, veteran status, or disability status