Associate / Senior Associate, Clinical Data Management

Location: Remote, Yardley, Pennsylvania, United States

Company

hirify.global supports clinical research, clinical data management, and patient-centered research technologies.

What you will do

• Manage and review clinical and ePRO data, including video-based data collection, within EDC platforms and iTakeControl technology.
• Develop Data Management Plans, CRF Specifications, eCRFs, and study documentation.
• Support data transfers, exports, migrations, reconciliation, and reporting activities.
• Participate in site initiation visits, user acceptance testing, and product launches.
• Collaborate with sponsors, clinical sites, vendors, product, technical, and cross-functional teams.
• Support remote data monitoring and patient-centric research approaches across studies from startup through closeout.

Requirements

• 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 and proficiency in Microsoft Word, Excel, and PowerPoint.
• Experience level: 0–10 years.

Nice to have

• Experience in digital health, digital therapeutics, or mobile applications.
• Experience in rare diseases, gene therapy, or long-term follow-up studies.
• Experience working with central or specialty laboratories and vendors.
• Familiarity with CDISC, CDASH, SDTM, FHIR, OMOP, MedDRA, and WHO Drug standards and dictionaries.

Culture & Benefits

• Inclusive workplace that values diversity, equity, and inclusion.
• Commitment to equal opportunity and a non-discriminatory work environment.
• Remote work arrangement.