Insightec
Insightec
Posted 3 months ago
Internship
Miami, Florida
In Person
Smart Summary
Responsibilities
The intern will develop Python scripts for data automation and cleaning while supporting clinical data coding and validation. Additionally, they will perform quality assurance activities for the Trial Master File and assist in preparing study status summaries.
Qualifications
You are a current undergraduate student in a technical, data, life sciences, or engineering field with basic to intermediate Python skills. You possess strong attention to detail and an interest in Quality Assurance, Trial Master File (TMF) processes, or clinical data.
Must Have Skills for ATS
Python
pandas
GCP
TMF
Job Description
Insightec is a fast‑growing medical technology company on a mission to transform patient care through innovative, incisionless surgery. We use advanced focused‑ultrasound technology to help patients around the world access treatments that are safer, less invasive, and life‑changing.
As an intern, you’ll join a global team of people who are passionate about improving healthcare. Our culture is open, collaborative, and driven by our core values: Our Patients, Integrity, Team, Quality, and Innovation.
At Insightec, every voice matters—including yours. You’ll be encouraged to share ideas, learn from experts, and contribute to meaningful projects that support real clinical research.
This internship is in partnership with the Focused Ultrasound Foundation (FUSF), a medical research, education, and patient advocacy organization based in Charlottesville, Virginia.
What you will be doing:
· 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.
What you have:
· 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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