Senior External Data Strategy Lead

Merck

Puerto Bogotá

On-site

COP 60,000,000 - 90,000,000

Full time

3 days ago
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Job summary

Merck in Colombia is seeking a Senior Specialist, External Data Manager to lead trial-level external data strategy, transfer-spec development, and data readiness, ensuring regulatory compliance and cross-functional alignment. You will mentor junior analysts, oversee data quality oversight, risk identification, and collaborate with GDMS, IT, and study teams to deliver timely data for database lock.

This role requires 5+ years in data management or clinical trials and a strong track record in EDC,

Qualifications

  • Bachelor-level degree in life sciences or data-related field.
  • Minimum 5 years in data management or clinical trials.
  • Masters/Doctorate preferred with 2+ years experience.

Responsibilities

  • Lead external data strategy and delivery studies.
  • Develop transfer specifications and monitor data transfers.
  • Oversee data load issues and QA activities.
  • Mentor junior analysts and report metrics.
  • Coordinate with GDMS, IT, and cross-functional teams.
  • Maintain SOP, ICH-GCP compliance and audit readiness.

Skills

Data management
Mentoring
Project management
Stakeholder communication

Education

Bachelor's degree in Life Sciences or related field
Master's or Doctorate (preferred)

Tools

EDC platforms
eCOA
External data integrations
Data specifications drafting
UAT coordination

Job description

Merck in Colombia is seeking a Senior Specialist, External Data Manager to lead trial-level external data strategy, transfer-spec development, and data readiness, ensuring regulatory compliance and cross-functional alignment. You will mentor junior analysts, oversee data quality oversight, risk identification, and collaborate with GDMS, IT, and study teams to deliver timely data for database lock.

This role requires 5+ years in data management or clinical trials and a strong track record in EDC,

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