Senior Clinical Data Manager

Location: Remote in Brazil, Colombia, Mexico, Argentina, Chile, or Peru. Candidates must be legally authorized to work in the country of employment without employer sponsorship. Occasional travel may be required.

Company

hirify.global supports clinical research and the development of innovative therapies through clinical data management services.

What you will do

• Lead clinical data management activities for assigned clinical projects from study start-up through post-database lock, ensuring continuity, responsiveness, quality, and timely delivery.
• Oversee data entry processes, develop data entry guidelines, train clinical research personnel, and perform data entry quality control when required.
• Develop CRF specifications, assist with clinical database builds, conduct database UAT, maintain controlled build documentation, and oversee database quality.
• Define and oversee edit check and manual data review specifications, review and query clinical trial data, perform line-listing reviews, and produce patient- and study-level metrics.
• Manage data management documentation, including Trial Master File materials, SOPs, work instructions, and study-specific plans.
• Coordinate with sponsors, project teams, external data and EDC vendors, and cross-functional stakeholders on timelines, deliverables, operational issues, training, and data-related decisions.

Requirements

• Bachelor’s degree and/or a combination of related experience.
• At least 8 years of experience for a Senior Clinical Data Manager role.
• Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook.
• Ability to handle a variety of clinical research tasks, with excellent organizational and communication skills.
• Professional written and oral English communication skills.
• Experience using various clinical database management systems.
• Broad knowledge of drug, device, and/or biologic development and effective data management practices.
• Strong representational, leadership, interpersonal, oral, and written communication skills.
• Ability to undertake occasional travel.

Nice to have

• Experience in a clinical, scientific, or healthcare discipline.
• Experience with dictionary medical coding, including MedDRA and WHODrug.
• Understanding of CDISC standards, including CDASH, SDTM, and ADaM.
• Oncology and/or orphan drug therapeutic experience.
• Experience assisting with SAS programming and quality control of SAS programs.

Culture & Benefits

• Remote work arrangement within the listed LATAM countries.
• Work with sponsors, vendors, and cross-functional clinical research teams.
• Opportunities to lead cross-functional and organization-wide data management initiatives.
• Equal opportunity employment environment.