Specialist, External Data Manager, GDMS Clinical Data Management

Job Description
The Specialist, External Data Manager (EDM) supports teams in execution of trial-level external-data activities, authoring and maintaining transfer specifications and coordinating with service providers/IT for accurate ingestion. The role performs completeness, reconciliation, and traceability checks, applies standards and controlled terminology, and supports audit/inspection preparation and targeted process improvements. 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 elevate issues as appropriate.
- Support Specimen Lifecycle Management reconciliation and external data validation to ensure data are review
- and lock-ready for CDM (Clinical Data Management).
- Participate in service provider governance forums (e.g., kick-off and status meetings).
- Monitor service provider KPIs, metrics, and timelines; identify and communicate risks to study leads.
- Support (Company Research Laboratory Quality Assurance) in service provider qualification activities, audits, and CAPA resolution as required.
- Provide status updates on assigned checks and reconciliations in internal and external team meetings.
- Act as a reliable partner to (Integral Data Management & Standards) and cross-functional teams, aligning on priorities and closing feedback loops to support coordinated delivery.
- Proactively support the CDM Trial Lead in trial data quality oversight and risk identification.




- Support additional projects and continuous improvement initiatives as assigned, including (but not limited to) process, standards, and platform / tool efforts.
- Archive and maintain required external data documentation in the eTMF (electronic Trial Master File) per SOPs (Standard Operating Procedures), including service provider correspondence, mapping specifications, and transfer logs.
- Maintain compliance with SOPs, ICH-GCP (International Council for Harmonization
- Good Clinical Practice), and protocol-specific requirements to ensure inspection readiness. Qualifications & experience
- Bachelors of Arts or Sciences(preferred in Nursing, Pharmacy, Life science, Data / Information technology or Medical Technology; or equivalent educational experience)
- Minimum 2 years of experience working in data management, clinical trial operations or related field.
- Desirable Masters or Doctorate(preferred in Nursing, Pharmacy, Life sciences, Allied Health, Data / Information technology or Medical Technology)
- English proficiency: C1 level Technical skills
- Working understanding of the clinical development process and end-to-end trial data flow.
- Working knowledge of clinical trial data structures and tools, including electronic data capture (EDC) and other data acquisition tools (e.g. eCOA [electronic Clinical Outcomes Assessment]) as well as associated utilities for managing, extracting,



and reporting data.
- Able to interpret mapping rules, review load logs, and recognize common data-integration defect patterns.
- Basic knowledge of standards-library processes and working experience applying [Clinical Data Interchange Standards Consortium] (SDTM [Study Data Tabulation Model], CDASH [Clinical Data Acquisition Standards Harmonization]) and controlled vocabularies. Non-technical skills
- Communicates effectively (oral/written) with technical and business partners and electronic data providers; adapts style to audience.
- Collaborates effectively across functions; facilitates small working sessions and follows through on action items.
- Works independently with minimal guidance; proactively identifies risks and proposes options.
- Manages multiple tasks and priorities while maintaining focus on the critical path.
- Uses data and basic structured thinking to triage issues, document assumptions and decisions, and escalates appropriately. Enterprise Leadership Skills
- Networking & Partnerships | Develops effective working relationships across teams to support collaboration, coordinate activities, and achieve shared goals.
- Executional Excellence | Takes timely action to accomplish work goals in line with compliance standards, while demonstrating initiative and a proactive approach to achieving results.
- Ownership & Accountability | Takes ownership of assignments, maintains high standards for quality and performance, and is accountable for completing work effectively and reliably. Additional location(s) Compensation Information: Required

Skills:
Adaptability, Adaptability, Audit Readiness, Clinical Data Cleaning, Clinical Data Management, Clinical Information Systems, Clinical Researc

📌 Specialist, External Data Manager, GDMS Clinical Data Management (Bogotá)
🏢 Merck Gruppe - Msd Sharp & Dohme
📍 Bogotá