Clinical Data Manager (Companion Diagnostics)

Location: Remote within the United States, with the listed location in California

Salary: $105,280–$197,400 per year, plus bonus, stock, and benefits.

Company

hirify.global develops technologies and services for laboratory, diagnostics, pharmaceutical, and life sciences applications.

What you will do

• Lead end-to-end clinical data management for companion diagnostic studies, including acquisition, database design, review, reconciliation, quality control, database lock, and submission-ready datasets.
• Design, validate, maintain, and lock EDC/CRF systems in line with regulatory requirements and company procedures.
• Collaborate with Biostatistics and Programming to develop SDTM and ADaM datasets for PMA, 510(k), De Novo, NDA, BLA, and EU IVDR submissions.
• Develop data transfer specifications and agreements, coordinate timelines, and act as the liaison with pharmaceutical partners and external vendors.
• Author data management plans, CRFs, database specifications, SOPs, process flows, and other study documentation.
• Monitor data integrity, support inspection readiness, identify quality risks, and represent data management during audits and regulatory inspections.

Requirements

• Bachelor’s degree in Data Science, Computer Science, Information Technology, or a related field, or an advanced degree in pharmaceutical, medical, or biomedical sciences.
• 5–8 years of clinical data management experience in biotechnology, pharmaceuticals, medical devices, diagnostics, or companion diagnostic development.
• Hands-on experience with CDISC standards, including SDTM, ADaM, CDASH, and Define.xml.
• Experience designing and managing studies in EDC platforms such as Medidata Rave, Veeva CDMS/EDC, Oracle InForm, REDCap, or equivalent systems.
• Ability to interpret regulatory standards, guidance, and laws; manage multiple complex projects; and make independent decisions.
• Experience collaborating with external partners or regulatory bodies.

Nice to have

• Experience with oncology trials, biomarker-driven studies, companion diagnostics, precision medicine, or regulated IVD development.
• Knowledge of cancer diagnostics, oncology, or pathology.
• Advanced degree such as a master’s degree, Ph.D., Pharm.D., or M.D.

Culture & Benefits

• Full-time employment with a remote work option.
• Eligibility for bonus, stock, and benefits.
• Work with cross-functional clinical, regulatory, quality, biostatistics, programming, CRO, and pharmaceutical partner teams.
• Day shift with no stated end date.