Job Description
Activities may include, but are not limited to:
- Build, integrate, and maintain clinical databases and operational systems, including study setup, transformations, integrations, edit checks, reporting, and user testing.
- Support the design, development, testing, and maintenance of clinical technology solutions (e.g., EDC, RTSM, eCOA/ePRO) using programming frameworks and automation tools.
- Implement and validate data logic such as edit checks, derivations, and dynamic rules.
- Contribute to developing and validating tools that streamline design, build, and validation workflows.
- Use data literacy skills to transform collected data into meaningful insights.
- Help develop and maintain reporting solutions (dashboards, listings, visualizations).
- Assist in configuring, testing, and validating data sources for integrations and transformations.
- Perform routine troubleshooting of data ingestion/consumption issues and escalate non‑standard issues as needed.
- Develop data models and queries; optimize extracts, views, and performance.
- Validate system functionality and maintain compliant documentation to support audits and inspection readiness.
- Participate in process improvements, meetings, and special projects.
- Execute unit and integration testing; document test cases and defects; resolve issues; prepare releases under change control.
- Collaborate with GDMS and cross‑functional partners to clarify requirements, support UAT, and ensure coordinated, high‑quality delivery.
Education
- B.A. or B.S. degree (or current student), preferably in Biotechnology (primary focus). Candidates from Computer Science, healthcare‑related disciplines, or those with relevant skills and experience may also be considered.
Experience
- 1 year of experience in clinical data programming, data engineering, or related data-management/clinical operations activities
Technical Skills
- Basic proficiency in at least one programming language (Python, SQL, SAS, or R).
- Familiarity with data collection, integration, transformation, reporting, and visualization.
- Knowledge of scripting and automation tools for data ingestion, cleaning, and report generation.
- Ability to create simple dashboards and reports using approved tools, including queries and basic data models.
- Foundational testing skills for reporting assets (unit/integration), including test case creation, defect logging, and evidence preparation.
- Basic understanding of SDLC and validation practices such as change control and traceability.
- Working knowledge of GCP, data integrity principles, audit‑ready documentation, and established UAT/sign‑off procedures.
- Exposure to performance optimization techniques (query tuning, filters, parameters) and data quality controls.
- Ability to translate business needs into technical deliverables.
- English proficiency of at least B2+ level.
Soft Skills
- Prioritizes tasks, meets deadlines, and maintains clear, well‑organized documentation.
- Communicates effectively with timely updates, clarifying questions, and concise notes.
- Builds strong cross‑functional relationships and is open to feedback.
- Uses structured thinking to solve straightforward issues and escalates complex ones appropriately.
- Demonstrates eagerness to learn new processes and technologies.
- Shows strong attention to detail and adheres to SOPs and data privacy/compliance standards.
