Lead Clinical Data Manager

Location: Remote - US; approximately 10% travel may be required for business-critical activities.

Salary: $152K–$190K per year.

Company

hirify.global is a clinical-stage life-science and technology company developing medicines through an AI-driven discovery and development platform.

What you will do

• Serve as the primary Data Management contact for assigned clinical studies and coordinate with sponsors, CROs, vendors, and cross-functional teams.
• Manage clinical data activities from database setup and design through database lock, archival, and close-out.
• Lead database UAT, query management, data cleaning, and reconciliation of SAE, laboratory, IRT/RTSM, and ePRO data.
• Author and maintain Data Management Plans, Data Review Plans, CRF completion and review guidelines, medical coding guidelines, and data transfer agreements.
• Oversee CRO and EDC vendor performance, including deliverables, risk assessment, timelines, resource planning, and issue escalation.
• Represent Data Management in study teams, investigator meetings, working groups, inspections, and audits while supporting process improvements and SOP development.

Requirements

• BA/BS degree in a scientific discipline, nursing, business, or information systems.
• 7–10+ years of clinical data management experience, including sponsor- or CRO-side experience.
• Advanced knowledge of EDC systems, preferably Medidata Rave, and clinical data structures.
• Experience overseeing CRO and EDC vendor performance and deliverables.
• Strong knowledge of FDA regulations, ICH guidelines, Good Clinical Practice, HIPAA, and CDISC conventions including CDASH and SDTM.
• Oncology experience, including knowledge of RECIST and RANO response criteria, plus strong communication and cross-functional collaboration skills.

Nice to have

• Experience supporting health authority inspections or audits.
• Experience with Phase III pivotal studies.
• Working knowledge of SAS, Excel, Spotfire, Python, or other programming and reporting tools.

Culture & Benefits

• Inclusive environment focused on collaboration across diverse backgrounds and experiences.
• Company-paid healthcare and flexible spending accounts.
• Voluntary life insurance and 401(k) matching.
• Uncapped vacation.
• Access to an onsite gym and dining facilities at the San Diego site.