External Data Management Senior Specialist

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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• Current Contingent Workers apply HERE

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• Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

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*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.