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, 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 of 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, facilita