Senior Clinical Data Manager

Location: Remote, United States

Salary: $133,900–$200,900 USD annually, plus a discretionary annual bonus.

Company

hirify.global provides clinical solutions and supports clinical research and drug, device, and biologic development programs.

What you will do

• Lead clinical data management activities for assigned projects from study start-up through post-database lock, serving as the primary Data Management contact.
• Oversee data entry, training, resourcing, quality control, timelines, metrics, and clinical data management deliverables.
• Develop CRF specifications, support clinical database builds, conduct UAT, maintain controlled documentation, and oversee edit-check and manual-review specifications.
• Review and query clinical trial data, perform line-listing and patient/study-level reporting, medical coding, and SAE/AE reconciliation.
• Coordinate sponsors, vendors, and cross-functional project teams; identify operational issues and support resolution.
• Contribute to SOPs, protocols, SAPs, CSRs, proposals, training, software demonstrations, and organization-wide initiatives; occasional travel may be required.

Requirements

• Bachelor’s degree and/or a combination of related experience.
• 8+ years of experience as a Clinical Data Manager.
• Experience with various clinical database management systems and broad knowledge of drug, device, and/or biologic development and effective data management practices.
• Professional use of English in written and oral communication.
• Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook.
• Excellent organizational, communication, representational, leadership, and interpersonal skills.
• Ability to handle varied clinical research tasks and undertake occasional travel.
• Candidates must be legally authorized to work in the United States without employer sponsorship.

Nice to have

• Experience in a clinical, scientific, or healthcare discipline.
• Medical coding experience with MedDRA and WHODrug.
• Understanding of CDISC standards, including CDASH, SDTM, and ADaM.
• Oncology and/or orphan drug therapeutic experience.

Culture & Benefits

• Remote work arrangement within the United States.
• Health insurance, retirement savings benefits, life insurance, disability benefits, parental leave, and paid sick leave and vacation.
• Eligibility for a discretionary annual bonus.
• Employment decisions are made without regard to legally protected characteristics.