Clinical Data Manager II

Location: Remote, United States. Occasional travel may be required. Candidates must be legally authorized to work in the country of employment without employer sponsorship.

Salary: $100,700–$166,100 USD annually, plus discretionary annual bonus and benefits.

Company

hirify.global provides clinical solutions and supports clinical research and data management projects for sponsors and clients.

What you will do

• Manage clinical trial data management activities from study start-up through post-database lock for assigned projects under some supervision.
• Serve as Lead Data Management contact or project contributor, coordinate timelines and resources, and communicate with sponsors, vendors, and project teams.
• Develop CRF specifications, assist with clinical database builds, conduct database UAT, maintain controlled documentation, and oversee database quality.
• Specify and review electronic and manual edit checks, query clinical trial data, perform line-listing reviews, and produce patient- and study-level metrics.
• Perform medical coding, coordinate SAE/AE reconciliation, support data entry and quality control, and assist with SAS programming and QC when required.
• Train clinical research personnel and data management team members; identify operational issues and contribute to SOPs, protocols, SAPs, CSRs, proposals, and project meetings.

Requirements

• Bachelor’s degree and/or a combination of related experience.
• 5+ years of Clinical Data Management experience or demonstrated aptitude in the key skills required for the role.
• Experience using a clinical database management system.
• Broad knowledge of drug, device, and/or biologic development and effective data management practices.
• Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook.
• Ability to handle a variety of clinical research tasks and maintain excellent organizational and communication skills.
• Fluent English reading, writing, speaking, and comprehension required for communication across Precision for Medicine and with clients.
• Ability to undertake occasional travel.

Nice to have

• Understanding of dictionary medical coding, including MedDRA and WHODrug.
• Understanding of CDISC standards, including CDASH, SDTM, and ADaM.
• Oncology therapeutic experience.

Culture & Benefits

• Remote work in the United States with occasional travel.
• Health insurance, retirement savings benefits, life insurance, disability benefits, parental leave, and paid sick leave and vacation.
• Employment decisions are made without regard to protected characteristics as an Equal Opportunity Employer.