Intern, Quality Assurance – Database Management
Location
United States
Posted
8 days ago
Salary
0
Seniority
Entry Level
Job Description
Intern, Quality Assurance – Database Management
INSIGHTEC
• Collaborating with the Data Manager to develop and refine Python scripts for data cleaning, formatting, mapping, and workflow automation. • Supporting clinical data coding processes (e.g., adverse events, concomitant medications, visit‑level mapping) and generating basic data validation reports. • Supporting Quality Assurance activities for the Trial Master File (TMF), including document quality checks, completeness review, version control verification, and audit readiness tasks. • Assisting with TMF documentation classification, metadata reconciliation, KPI tracking, and process improvement activities across Clinical & Quality Affairs. • Assist with preparing simple study status summaries (e.g., enrollment snapshots, milestone trackers) to help understand how Clinical Affairs monitors study progress across sites. • Support process documentation updates by helping draft or format flowcharts, checklists, or quick-reference guides used by Clinical Operations and QA. • Participating in cross‑functional meetings with Clinical Operations, Data Management, and QA teams to support ongoing study activities and continuous improvement initiatives. • Working according to Insightec Quality Policy, relevant Quality Procedures & Standards, and applicable privacy & safety rules.
Job Requirements
- Current undergraduate student in a technical, data, life sciences, or engineering field.
- Basic–intermediate Python skills (e.g., scripting, pandas).
- Strong attention to detail and interest in QA, TMF processes, or clinical data.
- Preferred: familiarity with clinical research terminology or GCP.
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