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 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.

·       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.

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·       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.

·       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.