Specialist, Data Architect

Job Description

The Specialist, Data Architect, GDMS Data Integration and Automation executes building, integrating, and maintaining clinical databases / clinical operational systems.  In addition, this role executes clinical study systems setup, transformations, integrations, edit checks, reports, and user testing - aligned to standards and study documentation. The Specialist, Data Architect is involved in governance of cross-study programming environments, including management of libraries, code baselines, and terminologies and management of in-life support, change/incident tracking, while driving continuous improvement.

Responsibilities

Programming and reporting

·       Design, build, test, and maintain clinical technology systems (e.g., EDC [Electronic Data Capture], RTSM [Randomization & Trial Supply Management], eCOA/ePRO [electronic Clinical Outcome Assessment/ electronic Patient-Reported Outcome]) with moderate guidance using programming / reporting frameworks and automation tools, ensuring quality and compliance.

·       Implement and validate complex data logic (edit checks, derivations, dynamic rules) using scripting and validation frameworks, with guidance as needed.

·       Propose and implement tools to streamline design, build, and validation processes.

·       Apply data literacy to transform collected data into actionable insights.

·       Develop advanced reporting solutions (dashboards, listings, visual analytics) using enterprise platforms; incorporate reusable components and role-based access.

Data Engineering

·       Configure, test, and validate data sources for integrations and transformations across internal and external systems, using standard procedures and with guidance as needed.

·       Collaborate with stakeholders to translate business needs into data and system requirements.

·       Troubleshoot straightforward issues in data ingestion and consumption processes and apply standard fixes, escalating non-routine problems to senior colleagues.

·       Develop robust data models, semantic layers, and curated datasets; monitor pipelines and enforce quality checks using established procedures with moderate guidance.

Process

·       Validate system functionality and ensure compliance with SOPs (Standard Operating Procedures) and regulations.

·       Identify process gaps and contribute to continuous improvement initiatives.

·       Maintain documentation for changes and incidents to support audit readiness.

·       Mentor junior colleagues, share best practices, and support onboarding and training.

·       Support release management processes for various business needs across environments (data management/clinical operations), including change control and risk assessment.

·       Align stakeholders by translating requirements into technical specs; lead UAT (User Acceptance Testing), capture feedback, and improve reporting standards.

·       Partner across teams to turn data and technical findings into clear, actionable stories

·       Act as a reliable partner to GDMS (Global Data Management & Standards) and other cross-functional teams, actively seeking input, aligning on priorities, and closing feedback loops to drive high-quality, coordinated delivery.

Technical skills

·       Foundational to intermediate-level proficiency in more than one programming language (e.g., SQL, Python, SAS, and R) for implementing clinical data collectors, integrations, transformations, reporting and visualizations

·       Proficiency with key tools and platforms used in the data-management ecosystem (e.g., data capture, review/visualization, reconciliation, reporting, or validation tools), with the ability to learn new technologies with guidance.

·       Ability to execute technical requirements on straightforward tasks independently, seeking moderate guidance for non-standard work.

·       Experienced in scripting and automating data ingestion, cleaning, and reporting processes using established methods, with guidance for complex automation.

·       Strong working knowledge of how clinical data are collected, processed, reviewed, reconciled, and reported across the study lifecycle.

·       Familiarity with common clinical and regulatory data standards, clinical operations, and data structures typical of clinical trials and related sources (e.g., electronic forms, external data feeds, operational systems).

·       Knowledge of System Development Lifecycle and validation practices (change control, release checklists, traceability from requirements to test evidence).

·       Understanding of Good Clinical Practice (GCP), data integrity, and audit-ready documentation; familiarity with UAT and sign-off processes.

·       Experience in report performance optimization (query tuning, filters/parameters) and data quality controls for reporting and analytics.

·       Ability to connect business outcomes to technical deliverables on straightforward problems, using standard procedures and seeking guidance for complex cases.

Non-technical skills

·       Prioritize tasks, meet deadlines, maintain clean documentation of assumptions, decisions, and next steps.

·       Communicate effectively (oral/written) with technical and business partners and external service providers; adapt style to audience.

·       Work independently with minimal guidance; triage issues using data; proactively flag risks and propose options.

·       Collaborate smoothly across functions; facilitate small working sessions; follow through on action items.

·       Establish positive working relationships across functions; receptive to feedback.

Enterprise Leadership Skills

·       Execution Excellence | Focus on self-development, openness to feedback, and quickly building skills; embrace continuous learning and actively identify new areas for growth

·       Decision Making | Identify and analyze problems by interpreting qualitative and quantitative information, select best course of action, and make timely decisions while considering tradeoffs; optimize probable consequences

·       Networking & Partnerships | Build knowledge of the company, processes, clients, and customers; work across functions and collaborate effectively; leverage relationships within and across work groups to achieve results

Qualifications & experience

·       Non-Degree with a minimum of 4 years of experience working in clinical data programming, data engineering, or related data-management/clinical operations functions.

OR

·       [Minimum preferred] Associate's Degree with a minimum of 3 years’ experience working in clinical data programming, data engineering, or related data-management/clinical operations functions.

OR

·       Bachelor's Degree with a minimum of 2 years’ experience working in clinical data programming, data engineering, or related data-management/clinical operations functions.

OR

·       Advanced Degree (Masters or Doctorate) with prior experience in clinical development and / or clinical data programming, data engineering, or related data management/clinical operations activities preferred.

Additional location(s) Compensation Information:

Required Skills:

Clinical Databases, Clinical Data Cleaning, Clinical Data Management, Clinical Development, Continuous Improvement Techniques, Data Analysis, Database Development, Data Ingestion, Data Literacy, Data Processing, Data Quality Assurance, Data Review, Data Validation, Data Visualization, Electronic Data Capture (EDC), Good Clinical Practice (GCP), Pharmacovigilance, Release Management, User Acceptance Testing (UAT)

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:

Domestic

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

11/16/2026

*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.