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Associate Director, Clinical Data Management Geography Lead, Colombia

msd · COL - Cundinamarca - Bogotá (Colpatria)

Nuevo
Hybrid Senior 🇬🇧 English
PL/SQL GDMS GCTO Good Clinical Practice 21 CFR Part 11

Descripcion del puesto

About the role

The Associate Director, Clinical Data Management (CDM) Geography Lead oversees day-to-day data-management operations and resources within the assigned geography in Colombia. The role ensures operational efficiency, compliance and quality delivery, supports regional strategy and resourcing, and partners with other leaders to promote consistent practices and staff development across sites.

Key responsibilities

  • Oversee daily data-management execution, quality, compliance and inspection readiness, and review the work of direct reports
  • Manage and develop local teams, align performance to GDMS standards and guide onboarding and skill building
  • Partner with the Portfolio and Resource Operations team on workload tracking, capacity and forecasting, and share lessons learned and best practices
  • Ensure adherence to GDMS/GCTO processes and local regulatory requirements, escalate risks and support mitigation
  • Lead recruiting and hiring, coordinate onshore/offshore and contingent resources, and manage an operating budget
  • Coach and develop direct reports, run check-ins and annual reviews, and handle sensitive employee-relations matters with HR

Required profile

  • Bachelor's degree (preferred in life sciences, data or information technology) with 8 years of data management experience, including clinical data management, clinical trial operations and large team management, plus 2 years of people leadership
  • OR advanced degree (Master's or doctorate) with 4 years of related data management experience and 2 years of people leadership
  • Fluent English with strong written and verbal communication

Required skills

  • Working knowledge of data-management operations, quality standards (GDMS, GCTO) and the clinical trial lifecycle
  • Experience with data standards, data flow and study start-up systems
  • Proficiency in workload planning, resourcing systems and performance metrics
  • Good Clinical Practice, 21 CFR Part 11, and inspection-readiness practices

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Source : ats:workday

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msd

COL - Cundinamarca - Bogotá (Colpatria)