Job Description

Activities may include, but are not limited to:

• 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.

• Design, develop, test, and maintain clinical technology systems (EDC, RTSM, eCOA/ePRO) using programming and automation frameworks.

• Implement and validate complex data logic such as edit checks, derivations, and dynamic rules.

• Propose and develop tools to streamline design, build, and validation workflows.

• Apply data literacy to convert collected data into actionable insights.

• Develop advanced reporting solutions, including dashboards and visual analytics, using enterprise platforms.

• Configure, test, and validate data sources for integrations and transformations across systems.

• Collaborate with stakeholders to translate business needs into technical and system requirements.

• Troubleshoot routine data ingestion and consumption issues, escalating non‑standard problems appropriately.

• Develop robust data models, semantic layers, and curated datasets while monitoring pipelines and enforcing quality checks.

• Validate system functionality and ensure adherence to SOPs, regulations, and compliance standards.

• Identify process gaps and contribute to continuous improvement initiatives.

• Maintain audit‑ready documentation for changes, incidents, and system updates.

• Mentor junior colleagues and contribute to onboarding and knowledge sharing.

• Support release management activities, including change control and risk assessment.

• Lead UAT activities, translate requirements into technical specifications, and refine reporting standards.

• Communicate data and technical findings clearly and partner across teams to enable coordinated, high‑quality delivery.

Education

• B.A. or B.S. degree (or current student), preferably in Biotechnology (primary focus). Candidates from Computer Science, healthcare‑related disciplines, or those with relevant skills and experience may also be considered.

Experience

• Minimum of 3 years experience working in in clinical data programming, data engineering, or related data-management/clinical operations functions.

Technical Skills

• Proficiency in multiple programming languages (SQL, Python, SAS, R) for implementing data collectors, integrations, transformations, and reporting.

• Skilled with key data‑management tools and platforms, with the ability to adopt new technologies with guidance.

• Able to execute technical tasks independently on straightforward work, seeking moderate guidance for non‑standard activities.

• Experienced in scripting and automating data ingestion, cleaning, and reporting processes.

• Strong understanding of clinical data flow across the study lifecycle (collection, processing, review, reconciliation, reporting).

• Familiarity with clinical and regulatory data standards, clinical operations, and typical clinical trial data structures.

• Knowledge of SDLC and validation practices, including change control, release checklists, and traceability.

• Understanding of GCP, data integrity, audit‑ready documentation, and UAT/sign‑off procedures.

• Experience optimizing reporting performance and applying data quality controls.

• Ability to link business needs to technical deliverables using standard procedures.

• English proficiency of at least B2+ level.

Soft Skills

• Prioritizes tasks, meets deadlines, and maintains clear, organized documentation.

• Communicates effectively with technical and business partners, adapting style to the audience.

• Works independently with minimal guidance, using data to triage issues and proactively flag risks with recommended options.

• Collaborates well across functions, facilitates small working sessions, and follows through on action items.

• Builds strong cross‑functional relationships and remains open to feedback.

Required Skills:

Adaptability, Clinical Data Cleaning, Clinical Data Management, Clinical Informatics, Clinical Medicine, Clinical Trial Documentation, Clinical Trials, Computer Science, Customer-Focused, Data Analysis, Database Development, Data Engineering, Data Literacy, Data Processing, Data Quality Assurance, Data Review, Data Validation, Data Visualization, Electronic Data Capture (EDC), Learning Agility, Pharmacovigilance, PL/SQL (Programming Language), Release Management, Standards Compliance

Preferred Skills:

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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:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

no

Job Posting End Date:

02/28/2026

*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.