Job Description

The Specialist, External Data Manager (EDM) 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 (Company 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 (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.

Qualifications & experience

• Bachelors of Arts or Sciences (preferred in Nursing, Pharmacy, Life science, Data / Information technology or Medical Technology; or equivalent educational experience)
• Minimum 2 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)
• English proficiency: C1 level

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 [Clinical Data Interchange Standards Consortium] (SDTM [Study Data Tabulation Model], CDASH [Clinical Data Acquisition Standards Harmonization]) and controlled vocabularies.

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.

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.

Additional location(s) Compensation Information:

Required Skills:

• Adaptability
• Audit Readiness
• Clinical Data Cleaning
• Clinical Data Management
• Clinical Information Systems
• Clinical Research
• Clinical Trials Monitoring
• Continuous Improvement Techniques
• Customer-Focused
• Data Analysis
• Database Concepts
• Database Development
• Data Ingestion
• Data Management
• Data Processing
• Data Quality Assurance
• Data Review
• Data Validation
• Data Visualization
• Delivery Coordination
• Drug Development
• Electronic Data Capture (EDC)
• Electronic Trial Master File
• Good Clinical Practice (GCP)

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

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