Clinical Data Manager

Location: Remote - Illinois

Company

hirify.global develops a precision medicine platform that connects real-world evidence with clinical insights to support treatment decisions.

What you will do

• Lead and contribute to clinical data management activities across all stages of clinical drug development.
• Lead cross-functional reviews of eCRF content and support EDC database builds, edit check reviews, and user acceptance testing.
• Monitor vendor data collection, coding, and cleaning through study metrics and targeted data reviews.
• Oversee database lock activities, data archiving, data cuts, transfers, and cross-functional data review plans.
• Collaborate with Biostatistics, Statistical Programming, Clinical Operations, Medical, Quality Assurance, Drug Safety, Pharmacovigilance, CROs, laboratories, and other vendors.
• Represent data management in internal and external meetings, manage timelines and deliverables, and support GCP inspection readiness.

Requirements

• BS/BA in a scientific discipline and at least 8 years of related experience in a CRO, pharmaceutical, biologics, or biotechnology company; an MS or equivalent is preferred.
• Experience with global studies, outsourced CRO models, study and vendor oversight, and all phases of clinical trials, particularly oncology and Phase 1 studies.
• Expert knowledge of clinical data management processes, EDC system design and build, and clinical trial data management systems.
• Knowledge of CDISC SDTM, CDASH, ICH GCP, regulatory requirements, and 21 CFR Part 11.
• Ability to lead cross-functional initiatives, manage managers and/or individual contributors, work independently, and communicate effectively with internal and external stakeholders.
• Proficiency in Microsoft Word and Excel.

Nice to have

• Experience with Medidata Rave EDC.
• Experience using MedDRA and WHODrug terminology.
• Prior experience working for both a sponsor company and a CRO.
• Early-phase clinical trial experience.

Culture & Benefits

• Values include commitment to people, innovation and discovery, urgency, open culture, and excellence.
• Emphasis on respectful collaboration, candid feedback, continuous learning, root-cause analysis, and results-focused problem solving.
• Full-time employment with benefits that may include incentive compensation, restricted stock units, medical coverage, and other benefits.
• Travel may be required.