Job Description The External Data Management (EDM) Specialist supports teams in execution of trial-level external-data activities, authoring and maintaining transfer specifications and coordinating with service providers/IT for accurate ingestion. The role performs completeness, reconciliation, and traceability checks, applies standards and controlled terminology, and supports audit/inspection preparation and targeted process improvements. Responsibilities Gather external data requirements from protocols, service providers, and study stakeholders. Develop external data specifications in accordance with standards, obtaining required stakeholder approvals. Execute test and first-production file reviews to confirm adherence to approved external data specifications. Monitor external data file loads, review error logs, and resolve or escalate issues as appropriate. Support Specimen Lifecycle Management reconciliation and external data validation to ensure data are review- and lock-ready for CDM (Clinical Data Management). Participate in service provider governance forums (e.g., kick-off and status meetings). Monitor service provider KPIs, metrics, and timelines; identify and communicate risks to study leads. Support our company’s Research Laboratory Quality Assurance in service provider qualification activities, audits, and CAPA resolution as required. Provide status updates on assigned checks and reconciliations in internal and external team meetings. Act as a reliable partner to GDMS (Global Data Management & Standards) and cross-functional teams, aligning on priorities and closing feedback loops to support coordinated delivery. Proactively support the CDM Trial Lead in trial data quality oversight and risk identification. Support additional projects and continuous improvement initiatives as assigned, including (but not limited to) process, standards, and platform / tool efforts. Archive and maintain required external data documentation in the eTMF (electronic Trial Master File) per SOPs (Standard Operating Procedures), including service provider correspondence, mapping specifications, and transfer logs. Maintain compliance with SOPs, ICH-GCP (International Council for Harmonization - Good Clinical Practice), and protocol-specific requirements to ensure inspection readiness. Required technical skills Working understanding of the clinical development process and end-to-end trial data flow. Working knowledge of clinical trial data structures and tools, including electronic data capture (EDC) and other data acquisition tools (e.g. eCOA [electronic Clinical Outcomes Assessment]) as well as associated utilities for managing, extracting, and reporting data. Able to interpret mapping rules, review load logs, and recognize common data-integration defect patterns. Basic knowledge of standards-library processes and working experience applying CDISC [Clinical Data Interchange Standards Consortium] (SDTM [Study Data Tabulation Model], CDASH [Clinical Data Acquisition Standards Harmonization]) and controlled vocabularies (e.g., LOINC [Logical Observation Identifiers Names and Codes]) Required non-technical skills Communicates effectively (oral/written) with technical and business partners and electronic data providers; adapts style to audience. Collaborates effectively across functions; facilitates small working sessions and follows through on action items. Works independently with minimal guidance; proactively identifies risks and proposes options. Manages multiple tasks and priorities while maintaining focus on the critical path. Uses data and basic structured thinking to triage issues, document assumptions and decisions, and escalate appropriately. Required Enterprise Leadership Skills Networking & Partnerships | Develops effective working relationships across teams to support collaboration, coordinate activities, and achieve shared goals. Executional Excellence | Takes timely action to accomplish work goals in line with compliance standards, while demonstrating initiative and a proactive approach to achieving results. Ownership & Accountability | Takes ownership of assignments, maintains high standards for quality and performance, and is accountable for completing work effectively and reliably. Candidates must meet one of the following qualifications: 4+ years of experience in data management, clinical trial operations, or a related field; or Associate's degree in any field and 3+ years of experience in data management, clinical trial operations, or a related field. Degrees in Nursing, Pharmacy, Life Sciences, Information Technology, Data Science, Medical Technology, or related disciplines are preferred; or Bachelor's degree in any field and 2+ years of experience in data management, clinical trial operations, or a related field. Degrees in Nursing, Pharmacy, Life Sciences, Information Technology, Data Science, Medical Technology, or related disciplines are preferred; or Master's degree or Doctorate in any field, preferably Nursing, Pharmacy, Life Sciences, Allied Health, Information Technology, Data Science, Medical Technology, or a related discipline. Additional location(s) Compensation Information: Required Skills: Clinical Data, Clinical Databases, Clinical Data Management, English Language, Services Management, Vendor Management Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully 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. Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

External Data Management Specialist.

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