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 crossstudy 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 nonstandard 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 auditready 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 highquality delivery.

Education:

• B.A. or B.S. degree in Biotechnology Computer Science healthcarerelated 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 datamanagement 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 nonstandard 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 auditready documentation and UAT/signoff 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 crossfunctional relationships and remains open to feedback.

Required Skills:

Preferred Skills:

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Relocation:

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