Specialist, External Data Manager, GDMS Clinical Data Management

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, 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) {+ 9 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
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