Job Description

The External Data Management Senior Specialist 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.

Responsibilities

• 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 priorities and closing feedback loops.
• Collaborate with 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.

Technical skills

• Working understanding 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 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.

Enterprise Leadership Skills

• 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.
• Ownership & Accountability | Establishes high standards for performance, takes responsibility for delivering on commitments, and ensures work is executed with accountability, quality, and follow-through.

Candidates must meet one of the following qualifications:

• 8+ years of experience in data management, clinical trial operations, or a related field, or;

• Associate's Degree in any field with minimum 7 years of experience working in data management, clinical trial operations, or a related field. Degrees in Nursing, Pharmacy, Life Sciences, Data / Information Technology, Medical Technology, or related disciplines are preferred, or;

• Bachelor's Degree in any field with minimum 5 years of experience working in data management, clinical trial operations, or a related field. Degrees in Nursing, Pharmacy, Life Sciences, Data / Information Technology, Medical Technology, or related disciplines are preferred, or;

• Advanced Degree (Masters or Doctorate) in any field. Degrees in Nursing, Pharmacy, Life Sciences, Allied Health, Data / Information Technology, Medical Technology, or related disciplines are preferred.

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