Hybrid External Data Manager – CDM Specialist

Merck Gruppe - MSD Sharp & Dohme; Bogotá; Hybride; COP 190 223 000 - 285 334 000; Plein temps

Résumé du poste

Merck Gruppe - MSD Sharp & Dohme is seeking an experienced Specialist, External Data Manager to support trial-level external-data activities. You will author transfer specifications, coordinate with service providers, and ensure data ingestion aligns with CDM standards.

The role emphasizes completeness, reconciliation, traceability, and audit readiness, while supporting process improvements and governance forums across teams.

Qualifications

• Minimum 2 years in data management or related field.
• Bachelor's degree in life sciences or related field.
• Masters/Doctorate preferred; English proficiency at C1 level.

Responsabilités

• Develop external data specifications and obtain approvals.
• Review tests and production file loads for compliance.
• Monitor data transfers, review logs, resolve issues.
• Support data validation, QA audits, and CAPA as needed.
• Collaborate with cross-functional teams for timely delivery.

Connaissances

External Data Manager

Clinical Data Management

Data Quality Assurance

SDTM/CDASH

EDC systems

Data Ingestion

Audit Readiness

Formation

Bachelor's in Life Sciences

Masters/PhD preferred

Outils

EDC tools

eCOA

Description du poste

Merck Gruppe - MSD Sharp & Dohme is seeking an experienced Specialist, External Data Manager to support trial-level external-data activities. You will author transfer specifications, coordinate with service providers, and ensure data ingestion aligns with CDM standards.

The role emphasizes completeness, reconciliation, traceability, and audit readiness, while supporting process improvements and governance forums across teams.