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Trial Strategy & Delivery (TSD) Intern

Remote · USA Full-time New today

Genmab is an international biotechnology company focused on improving patient lives through innovative antibody therapeutics. As a Trial Strategy & Delivery (TSD) Intern, you will gain hands-on exposure to clinical trial planning and operations, contributing to projects aimed at enhancing clinical trial efficiency and execution.

Responsibilities

  • Contribute to one or more of the following initiatives:
  • Clinical Trial Systems and Process Optimization Support enhancements to Genmab’s suite of operational software or contribute to building new tools, including requirements gathering, testing, and process documentation
  • Operational Data and Metrics Develop tools and templates in Excel, SharePoint, and MS Project to automate tracking of study timelines, resource metrics, and deliverables
  • Regulatory and Quality Documentation Assist in maintaining high-quality documentation and compliance tracking aligned with regulatory standards using systems such as Veeva Vault or Box
  • Cross-Functional Collaboration Partner with the broader Development Operations, Regulatory Affairs, and Portfolio and Project Management teams to streamline data flow and ensure consistency across systems and study teams
  • Analytical Support and Insights Contribute to the design and delivery of data analyses for key performance metrics, supporting decision-making in clinical trial planning and execution

Skills

  • Pursuing a Master's or advanced Bachelor's degree in Life Sciences, Biomedical Engineering, Regulatory Affairs, or a related discipline
  • Strong analytical and organizational skills with proficiency in Microsoft Office Suite (Excel, Word, PowerPoint, SharePoint)
  • Demonstrated ability to manage data, documentation, or process improvement projects
  • Excellent communication, teamwork, and problem-solving skills
  • Experience with Planisware, Veeva Vault, or other trial management systems
  • Background in clinical operations, regulatory affairs, or medical technology research
  • Familiarity with data analysis tools (e.g., R, Python, Tableau) and process automation
  • Exposure to market research or regulatory submission processes

Company Overview

  • Genmab is a biotechnology company focused on developing fully human antibody therapeutics for the potential treatment of cancer. It was founded in 1999, and is headquartered in Copenhagen, Hovedstaden, DNK, with a workforce of 1001-5000 employees. Its website is https://www.genmab.com.
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