External Data Manager: CDM & Trial Data Quality

MSD

Guaduas

Hybrid

COP 60,000,000 - 120,000,000

Full time

6 days ago
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Job summary

MSD is seeking a Specialist, External Data Manager to oversee trial-level external-data activities, author transfer specifications, and coordinate with IT for accurate ingestion. The role ensures completeness, reconciliation, traceability, and supports audit readiness.

Responsibilities include gathering requirements, developing specs, validating data loads, and collaborating with cross-functional teams to ensure timely, compliant data delivery.

Qualifications

  • Bachelor's degree or higher in life sciences, data science, or related field.
  • Minimum 2 years in data management, clinical trials, or related area.
  • Masters/Doctorate preferred in nursing, pharmacy, life sciences, allied health, or IT.
  • English proficiency at C1 level.

Responsibilities

  • Gather external data requirements from protocols, providers, and stakeholders.
  • Develop external data specifications and obtain approvals.
  • Review test and first-production file adherence to specs.
  • Monitor external data loads, review error logs, and resolve issues.
  • Support CDM data quality and validation for inspection readiness.

Skills

Data management
Clinical trials
EDC systems
SDTM/CDASH mapping

Education

Bachelor's degree in Life Sciences or related field

Tools

EDC tools
eCOA systems
CDISC standards

Job description

MSD is seeking a Specialist, External Data Manager to oversee trial-level external-data activities, author transfer specifications, and coordinate with IT for accurate ingestion. The role ensures completeness, reconciliation, traceability, and supports audit readiness.

Responsibilities include gathering requirements, developing specs, validating data loads, and collaborating with cross-functional teams to ensure timely, compliant data delivery.

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