Director Data Management (Clinical Data Management)

Location: United States; hybrid work with regular onsite collaboration at a hirify.global office

Company

hirify.global builds longitudinal, multimodal clinical evidence for pharmaceutical, biotech, provider, and payer organizations to support clinical, regulatory, and strategic decision-making.

What you will do

• Lead the design, configuration, validation, and maintenance of EDC databases across prospective studies, clinical trials, external control arms, and registry cohorts.
• Own database specifications, edit checks, derivations, UAT, study amendments, migrations, and integrations with laboratory, ePRO/eCOA, imaging, biomarker, and EHR-derived data.
• Establish CRF and data collection standards aligned with CDISC CDASH and govern data management standards, conventions, and SOPs.
• Oversee medical coding for adverse events, medical history, and concomitant medications using MedDRA and WHODrug.
• Direct SDTM, ADaM coordination, annotated CRFs, define.xml, reviewer’s guides, and Pinnacle 21 conformance checks for FDA/EMA submission readiness.
• Lead data cleaning, query management, reconciliation, database lock, quality metrics, audits, inspections, team development, and CRO/vendor oversight.

Requirements

• Bachelor’s degree in life sciences, health informatics, computer science, or a related field.
• 10+ years of clinical data management experience, including 3+ years leading or managing teams in a pharma, biotech, CRO, or RWE setting.
• Hands-on experience building and validating EDC databases such as Medidata Rave, Veeva Vault CDMS, Oracle Clinical, or similar platforms.
• Proficiency with CDISC CDASH, SDTM, and ADaM, including define.xml, annotated CRFs, and reviewer’s guides.
• Experience overseeing medical coding with MedDRA and WHODrug, plus strong knowledge of ICH-GCP, 21 CFR Part 11, and FDA/EMA requirements.
• Experience managing CROs and vendors, budgets, resources, and multiple concurrent studies to deadline.

Nice to have

• SCDM certification (CCDM) or equivalent.
• Experience with real-world evidence, registries, external control arms, or EHR-derived data.
• Familiarity with Pinnacle 21, SAS, or data-review programming.
• Therapeutic-area experience in hepatology, dermatology, or gastroenterology.

Culture & Benefits

• Hybrid work arrangement with regular onsite collaboration.
• Comprehensive health, dental, and vision coverage.
• 401(k) with company match.
• Generous PTO and paid parental leave.