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.
Additional location(s) Compensation Information:
Required Skills:
Clinical Data Management, Data Management, English Language, Stakeholder Management, Vendor Management
Preferred Skills:
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Employee Status:
Regular
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Not Applicable
Shift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
11/9/2026
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