External Data Manager, GDMS Clinical Data Management

About the role

The Specialist, External Data Manager (EDM) supports teams in executing trial-level external-data activities, authoring and maintaining transfer specifications and coordinating with service providers and IT so that data are ingested accurately. The role performs completeness, reconciliation and traceability checks, applies standards and controlled terminology, and supports audit and inspection preparation.

Key responsibilities

• Gather external data requirements from protocols, service providers and study stakeholders, and develop specifications with their approval.
• Run test and first-production file reviews, monitor file loads and error logs, and resolve or escalate issues.
• Support specimen lifecycle reconciliation and external data validation so data are ready for review and lock in Clinical Data Management.
• Take part in service provider governance meetings, track KPIs and timelines and flag risks to study leads.
• Support service provider qualification, audits and CAPA resolution, and archive external data documentation in the eTMF.
• Keep compliance with SOPs, ICH-GCP and protocol requirements, and help the CDM Trial Lead with data quality oversight.

Required profile

• Bachelor's degree (preferred in Nursing, Pharmacy, Life sciences, Data/Information technology or Medical Technology); a Master's or doctorate is desirable.
• At least 2 years of experience in data management, clinical trial operations or a related field.
• C1 English proficiency.

Required skills

• Working knowledge of EDC, eCOA and data extraction/reporting tools, and ability to read mapping rules and load logs.
• Basic knowledge of SDTM, CDASH and controlled vocabularies.
• Ability to work independently, manage priorities and communicate clearly with technical and business partners.