Clinical Data Engineering Specialist

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 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 rules 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 (or current student) preferably in Biotechnology (primary focus). Candidates from Computer Science healthcarerelated disciplines or those with relevant skills and experience may also be considered.

Experience

• Minimum of 3 years experience working in database configuring data engineering or data management operations or 1 years of specific experience in clinical database programming and upstream/downstream clinical data model configuring

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 C1 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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