Senior Specialist, External Data Manager, GDMS Clinical Data Management

About the role

The Senior Specialist, External Data Manager leads trial-level external data strategy and delivery studies. The role owns transfer-spec development, monitors transfers through conduct and lock, drives defect triage and resolution, ensures regulatory and SOP compliance and data readiness, and mentors junior analysts. It also supports the CDM Trial Lead in trial-level data quality oversight and risk identification.

Key responsibilities

• Gather external data requirements from protocols, service providers and study teams, and ensure specifications are developed, compliant with standards and approved by stakeholders.
• Verify that test and first production files conform to approved specifications, oversee file loading, review error logs and drive resolution of data load issues.
• Support the CDM Trial Lead in data quality oversight and risk identification, and lead or support specimen lifecycle reconciliation and external data validation for CDM review and database lock.
• Lead service provider forums (kick-offs, status meetings), oversee KPIs, SLAs and metrics, and escalate risks to study leadership.
• Prepare performance metrics for management, relationship and governance forums, and support QA activities such as audits and CAPA resolution.
• Collaborate with GDMS, IT and other teams, troubleshoot platform and integration issues, and mentor junior analysts.
• Maintain compliance with SOPs, ICH-GCP and protocol processes, archive documentation in the eTMF, and contribute to continuous improvement projects.

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 5 years of experience in data management, clinical trial operations or a related field; 2 years preferred with a Master's or Doctorate.
• Experience preparing documentation for audits and inspections, and performing reconciliation, data lineage checks and reference-range or plausibility checks.
• Proven RCA of load and mapping defects, and contribution to UAT for external data feeds.

Required skills

• Working understanding of the clinical development process and trial data flow.
• Proficiency with EDC platforms, eCOA and external data integrations, including authoring edit checks and reconciliation specifications.
• Advanced authoring and maintenance of external data specifications, with versioning and change control.
• Trial-level metrics literacy (timeliness, completeness, defect rates).