Trial Master File & Site Management Intern

Genmab is an international biotechnology company dedicated to improving the lives of patients through innovative antibody therapeutics. The Trial Master File & Site Management Intern will assist in various functions within the Site Management & Feasibility department, gaining skills related to clinical trial site engagement and oversight of the clinical trial master file.

Responsibilities

• Ensure compliance of Trial Master File through validation and confirmation of accurate metadata
• Review 'Note to File' content to determine the correct TMF filing location
• Support with report trend and data analysis
• Create site performance reports using quantitative and qualitative feedback from key stakeholders
• Research and evaluate clinical trial institutions and networks to identify unique capabilities and assess patient populations in alignment with Genmab’s portfolio
• Provide site status updates to the clinical-trial team, actively participate in trial related meetings, as required
• Oversee operational site performance e.g. site timelines, enrollment, compliance, database lock readiness

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
• Ability to conduct literature or database research to identify healthcare institutions, networks, or population data
• Demonstrates a global mindset with the ability to adapt, communicate, and collaborate effectively with team members from around the world
• Demonstrates an interest in artificial intelligence and innovation
• Demonstrates initiative, a proactive attitude, and eagerness to learn in a fast-paced environment
• Familiarity with clinical trial processes or a general understanding of regulatory documentation is a plus
• Comfortable synthesizing qualitative and quantitative data into clear summaries or reports

Company Overview