CDS Developer II

Job description

Job Description Position overview: 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 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: 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: 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: Current Employees apply HERE Current Contingent Workers apply HERE 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: 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.