External Data Management Specialist

Merck; Województwo mazowieckie; In loco; PLN 150.000 - 190.000; Tempo pieno

Descrizione del lavoro

Merck is seeking an External Data Management (EDM) Specialist to support trial-level external-data activities, author transfer specifications, and coordinate ingestion with service providers and IT. The role ensures completeness, reconciliation, traceability, and standardization in data handling.

Responsibilities include gathering data requirements, developing specifications, and performing test/production reviews, while monitoring data loads, validating data for CDM readiness, and contributing

Competenze

• Familiarity with clinical data structures and end-to-end trial data flow.
• Knowledge of CDISC SDTM/CDASH and controlled vocabularies.
• Ability to interpret mapping rules and review load logs.
• Experience with data management in trials and external data handling.

Mansioni

• Gather external data requirements from protocols, service providers and stakeholders.
• Develop external data specifications with stakeholder approvals.
• Execute test and production file reviews for compliance with specifications.
• Monitor external data file loads and resolve issues from logs.
• Support data QC and ensure data are review- and lock-ready for CDM.
• Participate in service provider governance and KPI monitoring.
• Provide updates in team meetings and align with Global Data Management & Standards.

Conoscenze

Clinical development

EDC/CDISC

Data mapping

CDISC standards (SDTM/CDASH)

Communication

Collaboration

Independent work

Risk triage

Formazione

Bachelor's degree

Master's degree or Doctorate

Associate's degree (data management, life sciences, IT)

Strumenti

EDC systems

eCOA

Descrizione del lavoro

The External Data Management (EDM) Specialist 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., kickoff and status meetings).
• Monitor service provider KPIs, metrics, and timelines; identify and communicate risks to study leads.
• Support our company's 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 GDMS (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 Harmonisation – Good Clinical Practice), and protocol‑specific requirements to ensure inspection readiness.

Required 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 CDISC [Clinical Data Interchange Standards Consortium] (SDTM [Study Data Tabulation Model], CDASH [Clinical Data Acquisition Standards Harmonization]) and controlled vocabularies (e.g., LOINC [Logical Observation Identifiers Names and Codes]).

Required 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.

Required 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.

Candidates must meet one of the following qualifications:

• 4+ years of experience in data management, clinical trial operations, or a related field; or
• Associate's degree in any field and 3+ years of experience in data management, clinical trial operations, or a related field. Degrees in Nursing, Pharmacy, Life Sciences, Information Technology, Data Science, Medical Technology, or related disciplines are preferred; or
• Bachelor's degree in any field and 2+ years of experience in data management, clinical trial operations, or a related field. Degrees in Nursing, Pharmacy, Life Sciences, Information Technology, Data Science, Medical Technology, or related disciplines are preferred; or
• Master's degree or Doctorate in any field,