Specialist, External Data Manager, GDMS Clinical Data Management

MerckCOL - Cundinamarca - Bogotá (Colpatria)onsiteSalary not postedView the original posting at Merck ↗

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 escalate 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 (Global 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 criti

Tools named in this posting

veeva vault etmf

The people who work here are one introduction away.

We show you who they are and write your first message — the insider list for this posting is filling in now. You have one introduction. The rest follows.

People at Merck you can reach out to

18 of 63 public LinkedIn profiles found in searches for Merck list Merck in their headline — those are the ones you can be confident work there. Pick who to reach out to — we'll draft your message; you make the contact. The rest, when shown, are marked Unverified.

Profiles are public pages as indexed by the search engine — we never log in to LinkedIn or copy private data, and anyone can ask to be removed. Ask to be removed →

Start the conversation More Clinical data jobs