Senior CDM Trial Lead — Data Integrity & Strategy

MSD LATAM

Puerto Bogotá

On-site

COP 90,000,000 - 150,000,000

Full time

4 days ago
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Job summary

MSD LATAM in Colombia seeks an experienced CDM Trial Lead to drive end-to-end data management for assigned studies, ensuring quality, integrity, and regulatory compliance across the trial lifecycle. You will partner with cross-functional teams to translate study protocol into DM deliverables and contribute to process improvements within the GDMS community.

You will oversee data collection design, validation, and query resolution, develop risk-based quality oversight, and ensure inspection

Qualifications

  • Minimum 10 years of directly relevant experience in data management, clinical trial operations or related field.
  • Experience with regulatory standards and inspection readiness.
  • Experience leading end-to-end data management activities.

Responsibilities

  • Lead end-to-end data management activities from start-up to archival.
  • Oversee data collection design, validation, and query resolution across data sources.
  • Ensure data standards and compliant documentation across TMF.
  • Mentor and train CDMs andExternal Data Specialists.
  • Represent data management in governance forums and cross-functional teams.

Skills

Clinical Data Management
Data Standards
GCDMP/GCP
CDISC SDTM/CDASH
RBQM
Cross-functional collaboration

Education

Non-Degree or Associates Degree (preferred in Life sciences)
Bachelor's Degree (preferred in Life sciences)
Advanced Degree (Masters/PhD) (preferred)

Tools

EDC systems
eCOA
Data integration tools

Job description

MSD LATAM in Colombia seeks an experienced CDM Trial Lead to drive end-to-end data management for assigned studies, ensuring quality, integrity, and regulatory compliance across the trial lifecycle. You will partner with cross-functional teams to translate study protocol into DM deliverables and contribute to process improvements within the GDMS community.

You will oversee data collection design, validation, and query resolution, develop risk-based quality oversight, and ensure inspection

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