Job Description
Position overview:
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Build, integrate, and maintain clinical databases and study systems, including transformations, edit checks, reporting, and user testing, while supporting governance of cross‑study programming environments.
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Design, develop, test, and maintain clinical technology systems (EDC, RTSM, eCOA/ePRO) using programming and automation frameworks.
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Implement and validate complex data logic such as edit checks, derivations, and dynamic rules.
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Propose and develop tools to streamline design, build, and validation workflows.
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Apply data literacy to convert collected data into actionable insights.
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Develop advanced reporting solutions, including dashboards and visual analytics, using enterprise platforms.
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Configure, test, and validate data sources for integrations and transformations across systems.
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Collaborate with stakeholders to translate business needs into technical and system requirements.
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Troubleshoot routine data ingestion and consumption issues, escalating non‑standard problems appropriately.
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Develop robust data models, semantic layers, and curated datasets while monitoring pipelines and enforcing quality checks.
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Validate system functionality and ensure adherence to SOPs, regulations, and compliance standards.
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Identify process gaps and contribute to continuous improvement initiatives.
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Maintain audit‑ready documentation for changes, incidents, and system updates.
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Mentor junior colleagues and contribute to onboarding and knowledge sharing.
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Support release management activities, including change control and risk assessment.
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Lead UAT activities, translate requirements into technical specifications, and refine reporting standards.
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Communicate data and technical findings clearly and partner across teams to enable coordinated, high‑quality delivery.
Education:
- B.A. or B.S. degree in Biotechnology, Computer Science, healthcare‑related disciplines, or those with relevant skills and experience.
Experience:
- Minimum of 3 years experience working in in clinical data programming, data engineering, or related data-management/clinical operations functions.
Technical Skills:
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Proficiency in multiple programming languages (SQL, Python, SAS, R) for implementing data collectors, integrations, transformations, and reporting.
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Skilled with key data‑management tools and platforms, with the ability to adopt new technologies with guidance.
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Able to execute technical tasks independently on straightforward work, seeking moderate guidance for non‑standard activities.
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Experienced in scripting and automating data ingestion, cleaning, and reporting processes.
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Strong understanding of clinical data flow across the study lifecycle (collection, processing, review, reconciliation, reporting).
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Familiarity with clinical and regulatory data standards, clinical operations, and typical clinical trial data structures.
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Knowledge of SDLC and validation practices, including change control, release checklists, and traceability.
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Understanding of GCP, data integrity, audit‑ready documentation, and UAT/sign‑off procedures.
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Experience optimizing reporting performance and applying data quality controls.
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Ability to link business needs to technical deliverables using standard procedures.
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English proficiency of at least B2+ level.
Soft Skills:
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Prioritizes tasks, meets deadlines, and maintains clear, organized documentation.
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Communicates effectively with technical and business partners, adapting style to the audience.
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Works independently with minimal guidance, using data to triage issues and proactively flag risks with recommended options.
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Collaborates well across functions, facilitates small working sessions, and follows through on action items.
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Builds strong cross‑functional relationships and remains open to feedback.
Required Skills:
Base SAS, Business Requirements Analysis, Clinical Data Management, Data Analysis, Data Quality Assurance, Data Quality Control, Data Reporting, Electronic Data Capture (EDC), Pharmacovigilance, PL/SQL (Programming Language), SQL Databases, Technical Requirements Gathering, User Acceptance Testing (UAT)
Preferred Skills:
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Employee Status:
Regular
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Hybrid
Shift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
09/30/2026
*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.
