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Clinical Data Manager

20 hours, 38 minutes ago
Mexico
Lead
Database Administrator
Database Administration
Apply Now
Precision For Medicine

Precision For Medicine

Precision for Medicine is a specialized scientific services company that helps pharmaceutical and life sciences clients innovate, develop, and commercialize next-generation medical products. With a diverse team of experts, they offer comprehensive serv...

Pharmaceuticals
1K-5K
Founded 2012
$225M raised
View All Jobs 80

Description

  • Serve as the primary data management contact for assigned clinical projects or programs and ensure continuity and timely execution.
  • Oversee data entry processes, including guidelines, training, quality oversight, and resourcing.
  • Develop CRF specifications from clinical study protocols and coordinate stakeholder review and feedback.
  • Build or support clinical databases, conduct database build user acceptance testing, and maintain build documentation.
  • Specify and oversee edit check and manual data review requirements.
  • Create, revise, version, and maintain data management documentation for the Trial Master File.
  • Train clinical research personnel and data management team members on study-specific tools and processes.
  • Review and query clinical trial data, perform line listing reviews, and produce patient- and study-level status and metric reports.
  • Coordinate SAE/AE reconciliation and perform medical coding to ensure consistency and logic.
  • Liaise with sponsors, vendors, and project teams; identify operational issues; and support SOP/process development and leadership initiatives.

Requirements

  • Bachelor’s degree and/or a combination of related experience.
  • 8+ years of experience for a Senior Clinical Data Manager or 10+ years for a Principal Clinical Data Manager.
  • Proficiency in Microsoft Office: Word, Excel, PowerPoint, and Outlook.
  • Experience using various clinical database management systems.
  • Broad knowledge of drug, device, and/or biologic development and data management practices.
  • Excellent organizational, communication, leadership, and interpersonal skills.
  • Professional written and spoken English.
  • Ability to handle a variety of clinical research tasks and occasional travel.
  • Preferred: experience in a clinical, scientific, or healthcare discipline.
  • Preferred: dictionary medical coding experience with MedDRA and WHODrug.
  • Preferred: understanding of CDISC standards such as CDASH, SDTM, and ADaM.
  • Preferred: oncology and/or orphan drug therapeutic experience.

Benefits

  • Remote role (#LI-REMOTE).
  • Opportunity to help build a growing LATAM data management team.
  • Chance to work across multiple countries in Latin America.
  • Reasonable accommodation support for applicants with disabilities.

Interested in this position?

Apply directly on the company website

Apply Now

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