Clinical Trials External Data Specialist

Merck

Puerto Bogotá

On-site

COP 50,000,000 - 90,000,000

Full time

3 days ago

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Job summary

Merck Colombia is seeking a Specialist, External Data Manager to support trial-level external-data activities, author transfer specifications, and coordinate ingestion with service providers and IT. You will ensure data completeness, reconciliation, traceability, and compliance with ICH-GCP and SOPs.

On the job, you will review external data specifications, monitor file loads, resolve issues, and contribute to CDM readiness.

Qualifications

Bachelor degree in life sciences or related field.
Minimum 2 years of experience in data management or clinical trials.
English proficiency at C1 level as required.

Responsibilities

Gather external data requirements from protocols, service providers, and study stakeholders.
Develop external data specifications in accordance with standards, obtaining required stakeholder approvals.
Execute test and first-production file reviews to confirm adherence to approved external data specifications.
Monitor external data file loads, review error logs, and resolve or escalate issues as appropriate.
Support CDM readiness and external data validation to ensure data review and lock readiness.
Participate in service provider governance forums and monitor KPIs, risks, and timelines.
Archive and maintain required external data documentation in the eTMF per SOPs.
Maintain compliance with SOPs, ICH-GCP, and protocol-specific requirements for inspection readiness.