Trial Master File Intern
Genmab
Summary
The Trial Master File Intern will support Genmab's drug development efforts, gaining hands on experience with the process and computerized systems used to manage clinical trial records that are critical to successful submission and approval of our medicines. This 10-week summer internship will provide opportunities to gain skills related to clinical trial site engagement and oversight of the clinical trial master file.
Job description
Job Overview
The Trial Master File Intern will support Genmab's drug development efforts, gaining hands on experience with the process and computerized systems used to manage clinical trial records that are critical to successful submission and approval of our medicines. This 10-week summer internship will provide opportunities to gain skills related to clinical trial site engagement and oversight of the clinical trial master file.
What You'll Do
- Assist with projects to improve business processes in TMF Operations, which can include writing or revising procedures, and updating templates and tools (e.g. the TMF Index).
- Participate in system enhancement projects, including software assessment and testing.
- Support with report development, trend and data analysis.
Required Qualifications, Capabilities And Skills
- Currently pursuing a Bachelor's in Life Sciences, Public Health, Data Science, or a related field.
- Strong Microsoft Applications skills e.g., Word, Excel and PowerPoint.
- Strong analytical skills with experience using Excel or other spreadsheet tools for data analysis and comparison.
- Strong computer skills and ability to learn technical applications in a fast-paced environment.
- Strong 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.
Preferred Qualifications, Capabilities And Skills
- Comfortable synthesizing qualitative and quantitative data into clear summaries or reports.
- Familiarity with clinical trial processes or a general understanding of regulatory documentation is a plus.
General Intern Information
Internships will take place over 10 weeks from June – August 2027. This role will be based in Princeton, NJ and operate on a required hybrid schedule – 3 days in the office and 2 days remote per week. This role is not eligible for work visa sponsorship at the time of the application or in the future.
Requirements
- Currently pursuing a Bachelor's in Life Sciences, Public Health, Data Science, or a related field
- Strong Microsoft Applications skills e.g., Word, Excel and PowerPoint
- Strong analytical skills with experience using Excel or other spreadsheet tools for data analysis and comparison
- Strong computer skills and ability to learn technical applications in a fast-paced environment
- Strong 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
- Comfortable synthesizing qualitative and quantitative data into clear summaries or reports
- Familiarity with clinical trial processes or a general understanding of regulatory documentation is a plus
Company overview
Genmab is a leading international biotechnology company headquartered in Copenhagen, Denmark, specializing in the development and commercialization of differentiated antibody therapeutics for the treatment of cancer. Founded in 1999, the company has established itself as a pioneer in antibody technology with its proprietary DuoBody, HexaBody, and DuoHexaBody platforms. Genmab's innovative approach focuses on creating next-generation antibody-based therapies that target specific cancer cells while minimizing damage to healthy tissues. The company has several marketed products including DARZALEX (daratumumab) for multiple myeloma, which has become a cornerstone treatment in hematological malignancies. Genmab's pipeline includes numerous clinical-stage candidates targeting various cancers, leveraging its expertise in antibody engineering to develop novel immunotherapies. The company collaborates with major pharmaceutical partners worldwide and maintains a strong commitment to advancing cancer treatment through cutting-edge science and patient-focused innovation.