CDS Developer II

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