Job Description

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 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 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 Harmonization - 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 escalate 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, preferably Nursing, Pharmacy, Life Sciences, Allied Health, Information Technology, Data Science, Medical Technology, or a related discipline.

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