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.

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 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.

• Qualifications & experience

• · 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.

• Technical skills

• · 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.

• 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.

Additional location(s) Compensation Information:

Required Skills

• Adaptability, Adaptability, Clinical Data Management, Clinical Research, Communication, Continuous Improvement Techniques, Data Analysis, Database Concepts, Database Lock, Data Loading, Data Management, Data Operations, Data Quality Assurance, Data Reporting, Data Review, Data Standards, Data Strategies, Data Validation, Electronic Trial Master File, Good Clinical Practice (GCP), Inspection Readiness, Leadership, Medical Terminology, Performance Metrics, Project Coordination {+ 6 more}

Preferred Skills:

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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:

• Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

• 11/2/2026*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.