Standards and Systems Intern

Genmab•Princeton, TX

7d•Hybrid

About The Position

At Genmab, we are dedicated to building extra[not]ordinary® futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines® that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals’ unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees. Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so. Does this inspire you and feel like a fit? Then we would love to have you join us! Job Title Standards and Systems Intern Why Genmab Our internship program provides interns with hands-on experience and relevant projects that directly align with our company’s goals. Additionally, we believe our program provides a valuable opportunity to learn, thrive, and build a strong network. We encourage you to review our website to learn why we’re always looking for smart, purpose-led candidates to play a role in our bold, extra[not]ordinary® future. 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 request and Service Now Request related to edc system user access, all through direct assignments and mentorship. The intern will also contribute to continuous process improvement initiatives by offering suggestions and completing assigned tasks that enhance departmental efficiency and quality. In addition to supporting the Standards & Systems team, the intern will collaborate with cross-functional teams, contributing to process improvements, development activities, and other projects that have a tangible impact on Genmab’s drug development efforts. What You’ll Do Contribute to meetings within the standards and systems group

Requirements

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.

Nice To Haves

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.

Responsibilities

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, ensuring that content is current, organized, and accessible
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