Senior Clinical Data Manager (Clinical Research)

Location: Remote within the United States; multiple states

Company

hirify.global is a data-focused clinical research organization supporting pharmaceutical, biotech, and medical device companies with clinical trial data management and regulatory submission services.

What you will do

• Lead clinical data management projects from study setup through close-out with limited management oversight.
• Advise clients on best-fit EDC solutions and coordinate directly with EDC and IWR suppliers.
• Oversee CRF tracking, data entry, external data integrations, validation, query resolution, coding, SAE reconciliation, database lock, and database QC audits.
• Develop and oversee study documentation, including annotated CRFs, CRF Completion Guidelines, validation specifications, and Data Management Plans.
• Coordinate protocol review, UAT, study timelines, metrics reporting, and cross-functional issue resolution.
• Mentor new clinical data managers and contribute to SOP, process, and system improvements.

Requirements

• Bachelor’s or Master’s degree in a scientific or healthcare field preferred, with relevant industry experience.
• 5+ years of experience in clinical data management, including at least 1 year leading projects.
• Extensive knowledge of paper CRF, EDC, and hybrid clinical data management systems.
• Extensive knowledge of Clinical Operations SOPs and working practices.
• Strong understanding of GCP, ICH guidelines, and applicable FDA regulations.
• Excellent verbal and written communication, interpersonal, organizational, independent problem-solving, and client-management skills.

Culture & Benefits

• Supportive, innovative, collaborative, and inclusive work environment.
• Remote work arrangement within the United States.
• Opportunity to work across pharmaceutical, biotech, and medical device clinical research programs.
• Global organization with operations across four continents.