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Senior Clinical Data Manager (Mexico)

5 hours, 20 minutes ago
Mexico
Full-time
Lead
Database Administrator
Database Administration
Apply Now
Precision Medicine Group

Precision Medicine Group

Precision Medicine Group specializes in precision medicine, utilizing targeted expertise and data insights to accelerate drug development and enhance the commercialization of next-generation medical products for the pharmaceutical and life sciences ind...

Pharmaceuticals
251-1K
Founded 2012
View All Jobs 126

Description

  • Serve as the primary data management contact for assigned clinical projects and programs, ensuring continuity, responsiveness, and timely execution.
  • Oversee the project data entry process, including data entry guidelines, training, quality, and resourcing.
  • Manage timelines and resource needs to ensure clinical data management deadlines are met with quality.
  • Develop CRF specifications from clinical study protocols and coordinate stakeholder review and feedback.
  • Build and test clinical databases, including conducting database build UAT and maintaining controlled build documentation.
  • Define and oversee edit check specifications and manual data review specifications.
  • Create, revise, version, and maintain data management documentation and ensure Trial Master File completeness.
  • Train clinical research personnel and data management team members on study-specific CRFs, EDC, and related project items.
  • Review and query clinical trial data, perform line listing data review, and run patient- and study-level status and metric reports.
  • Perform medical coding, coordinate SAE/AE reconciliation, and liaise with external vendors and project teams on data-related deliverables.

Requirements

  • Bachelor’s degree and/or a combination of related experience.
  • 8+ years of experience, or an equivalent combination of qualifications and relevant experience.
  • Professional-level English proficiency, both verbal and written.
  • 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 effective data management practices.
  • Excellent organizational, communication, leadership, interpersonal, and representational skills.
  • Ability to undertake occasional travel.
  • Experience in a clinical, scientific, or healthcare discipline is preferred.
  • Dictionary medical coding experience with MedDRA and WHODrug is preferred.
  • Understanding of CDISC standards such as CDASH, SDTM, and ADaM is preferred.
  • Oncology and/or Orphan Drug therapeutic experience is preferred.

Benefits

  • Remote work is indicated by the posting.
  • Equal opportunity employer status.
  • Reasonable accommodation support for applicants with disabilities.
  • Privacy and applicant data protections are provided during the application process.

Interested in this position?

Apply directly on the company website

Apply Now

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