Standards and Systems Intern

Job Overview

The Standards and Systems Intern will support Genmab's data standards, clinical systems, and standards governance activities by gaining hands-on experience in key components of clinical data management during a 10-week summer internship.

This role provides practical exposure to the foundational elements that ensure consistency, quality, and compliance in clinical data collection across Genmab trials. Working closely with the Standards & Systems team, the intern will develop an understanding of Genmab's core standards requirements, including Case Report Form (CRF) design, edit check testing and validation, processing standards change requests and ServiceNow requests related to EDC system user access, all through direct assignments and mentorship. The intern will also contribute to continuous process improvement initiatives.

What You'll Do

• Contribute to meetings within the standards and systems group
• Assist in the intake, review, and documentation of Standards Change Requests
• Participate in internal alignment discussions and cross-functional meetings related to implementation of standards
• Participate in validation activities for the build of standard Case Report Forms (CRFs) and edit checks
• Assist in updating and maintaining the Genmab Standard CRF Template and Allowable Modification and Usage (AMU) Guide
• Assist with filing standards and system documentation within eTMF, ensuring accuracy and inspection readiness
• Help process ServiceNow requests for EDC user access and monitor compliance with access-control procedures
• Maintain and update the Standards & Systems SharePoint site
• Attend standards and systems departmental meetings and/or study team meetings as required
• Contribute to drafting, updating, and improving departmental process documents, workflows, and best-practice guides

Required Qualifications, Capabilities And Skills

• Enrollment in a Bachelor or Master's program in Health Sciences, Data Science, or a related field
• Basic understanding of clinical trial regulatory environment
• Strong analytical and problem-solving abilities
• Excellent written and verbal communication skills
• Ability to work independently and as part of a collaborative team
• High attention to detail and commitment to quality work
• Genuine interest in clinical research and drug development

Preferred Qualifications, Capabilities And Skills

• Demonstrates initiative, a proactive attitude, and eagerness to learn in a fast-paced environment
• Effectively communicates and collaborates with team members, mentors, and stakeholders
• Applies academic expertise in open-source programming languages and adapts quickly to new tools and methodologies
• Maintains attention to detail and quality in all deliverables while managing multiple tasks
• Actively engages in the capstone project and leverages feedback to refine technical and professional skills