Senior Specialist, External Data Manager, GDMS Clinical Data Management

Job Description

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/SOP (Standard Operating Procedure) compliance and data readiness, and mentors' junior analysts while reporting metrics and lessons learned. They also support the CDM Trial Lead in trial-level data quality oversight and risk identification.

·         Gather external data requirements from protocols, service providers, and study teams.

·         Ensure external data specifications are developed, compliant with standards and approved by required stakeholders.

·         Verify that test and first production files conform to approved external data specifications.

·         Oversee external data file loading, review error logs, and drive resolution of data load issues.

·         Proactively support the CDM Trial Lead in trial-level data quality oversight and risk identification.

·         Lead or support Specimen Lifecycle Management reconciliation and external data validation activities to ensure data usability for CDM (Clinical Data Management) review and database lock.

·         Lead and participate in service provider forums (e.g., kick-off meetings, routine status meetings).

·         Oversee service provider KPIs, SLAs (Service Level Agreements), metrics, and adherence to timelines; identify and escalate risks to study leadership as needed.

·         Prepare and present required service provider performance metrics to management, relationship management, and governance forums.

·         Support QA (Quality Assurance) activities related to service provider qualification, audits, and CAPA resolution.

·         Act as a reliable partner to GDMS (Global Data Management & Standards), IT, and other cross-functional teams, aligning on priorities and closing feedback loops.

·         Collaborate with Company IT to troubleshoot and resolve complex platform or integration issues, escalating high-impact risks appropriately.

·         Mentor junior analysts on tools, checks, and service provider interactions.

·         Lead trial-level service provider management activities, including performance trending and issue/risk reviews.

·         Lead or participate in team meetings, providing clear status and feedback on assigned checks and reconciliations.

·         Contribute expertise, project management, and/or leadership to additional projects and continuous improvement initiatives, including (but not limited to) process, standards, and platform / tool efforts.

·         Maintain compliance with SOPs (Standard Operating Procedures), ICH-GCP (International Council for Harmonization - Good Clinical Practice), and protocol-specific processes.

Archive required documentation in the eTMF (electronic Trial Master File), including service provider correspondence, mapping specifications, and transfer logs, to ensure traceability and inspection readiness.

· Bachelors of Arts or Sciences (preferred in Nursing, Pharmacy, Life science, Data / Information technology or Medical Technology; or equivalent educational experience)

· Minimum 5 years of experience working in data management, clinical trial operations or related field.

·Desirable Masters or Doctorate (preferred in Nursing, Pharmacy, Life sciences, Allied Health, Data / Information technology or Medical Technology) with minimum 2 years of experience working in data management, clinical trial operations or related field.

·       Working understanding of the clinical development process and trial data flow.

·       Proficiency with electronic data capture (EDC) platforms, other data acquisition tools (e.g. eCOA [electronic Clinical Outcomes Assessment]) and external data integrations, including authoring edit check and reconciliation specifications (and/or programming where applicable).

·       Deep knowledge of appropriate application of standards and terminology; partners effectively with Standards on new terms and updates.

·       Experience preparing complete, well-organized documentation for audits and inspections.

·       Advanced authoring and maintenance of external data specifications with clear implementation guidance for service providers and IT; manages versioning and change control.

·       Deep experience executing reconciliation (cross-system completeness and consistency), end-to-end (E2E) data lineage and traceability, and reference-range or clinical plausibility checks to ensure accurate, audit-ready external data.

·       Proven RCA of load and mapping defects; defines corrective actions and contributes to UAT (User Acceptance Training) for external data feeds.

·       Trial-level metrics literacy (timeliness, completeness, defect rates) to target and verify improvements.

Non-technical skills

·       Communicates effectively (oral and written) with technical and business partners and external service providers; translates technical topics for non-technical stakeholders and adapts style to audience.

·       Manages difficult conversations constructively; negotiates timelines and quality expectations.

·       Demonstrated ability to provide mentorship to junior team members.

·       Demonstrated ability to lead day-to-day activities; drives issue triage to closure and coordinates stakeholders.

·       Prioritizes independently; escalates with context, impact, and recommendation.

·       Delivers crisp status, decisions, and blockers; maintains decision logs.

·       Networking & Partnerships | Develops and sustains productive relationships within and across functions to enable collaboration, alignment, and the achievement of shared goals.

·       Executional Excellence | Drives timely, proactive execution in line with compliance standards, overcoming barriers and delivering strong results that advance broader team and business priorities.

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