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Technical Project Manager

MSD LATAM · San Jerónimo District

Nuevo
🇬🇧 English
clinical database standards GxP integration edit checks validation

Descripcion del puesto

About the role

The Technical Project Manager leads end‑to‑end delivery of technical components for clinical trials within a drug or vaccine program. You will design, build, test, deploy and maintain study‑level technical deliverables while ensuring compliance with clinical data standards and GxP requirements.

Key responsibilities

  • Develop and maintain detailed project plans covering design, build, testing, deployment, run and close‑out of technical deliverables such as eCRFs, data‑collection systems, integrations, edit checks, listings, reports and archival.
  • Lead discovery sessions with study stakeholders to define technical requirements, assess complexity and set timelines.
  • Ensure consistent use of clinical database standards and manage change‑request intake and processing.
  • Orchestrate configuration and build activities with full traceability to requirements, providing status reporting and governance updates.
  • Tri­age defects, manage change requests, and maintain audit‑ready documentation throughout the study lifecycle.
  • Serve as the primary technical point of contact for the trial, representing Global Clinical Data Integration on cross‑functional teams.
  • Validate that all technical components are production‑ready before first‑patient‑first‑visit and support end‑of‑study archival and decommissioning.
  • Support audits and inspections, ensuring validation evidence meets SOP/GxP expectations.

Required profile

  • Bachelor’s degree (field not specified).

Required skills

  • Clinical database standards
  • GxP compliance
  • eCRF design and configuration
  • Data‑collection system implementation
  • System integration
  • Edit checks and derivations
  • Validation and audit‑ready documentation

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Publicado hace 2 días

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MSD LATAM

San Jerónimo District