Mgr, Database Management Systems (Clinical Data Standards)

Location: Durham, North Carolina, United States of America

Annual base pay: $84,600–$211,600

Company

hirify.global provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.

What you will do

• Develop and maintain global clinical data standards and operational mappings for eCRF, laboratory, imaging, ECG, and other data.
• Use CDISC SDTM, controlled terminology, and related industry standards to create and implement data standards.
• Build, maintain, and document Medidata Rave global library objects, including eCRF forms and edit checks.
• Coordinate standards governance activities, committee discussions, approvals, documentation, and cross-functional SOPs.
• Support study and project teams with CRF design, completion guidelines, edit checks, data transfer specifications, mapping specifications, and annotated CRFs.
• Lead strategic initiatives, provide training and mentoring, and collaborate with internal stakeholders and external partners.

Requirements

• Medidata Rave experience is required.
• Medidata Rave Custom Functions experience is required.
• C# programming experience is required.
• CDISC Standards Governance experience is required.
• Relevant education and experience in clinical data standards: a master’s degree with 4+ years, a bachelor’s degree with 6+ years, or a high school degree with 10+ years.
• Experience with clinical trials, SDTM, data mapping specifications, annotated CRFs, global library development, and clinical database development.

Nice to have

• Experience with CDASH or ADaM, define.xml, MedDRA, WHODrug, and other EDC tools such as Veeva, Medrio, Oracle, or TrialGrid.
• Knowledge of health authority regulations, GCP/ICH guidelines, SDLC principles, CRF design, query resolution, and data validation.
• Experience leading through influence across complex global organizational structures.

Culture & Benefits

• Work with stakeholders across clinical data management, clinical operations, development, commercial, regulatory, and quality functions.
• Contribute to global standards, process improvements, emerging data collection technologies, and cross-functional working groups.
• Health and welfare benefits may be provided in addition to base pay.