Trial Master File & Site Management Intern

Remote, USA Full-time
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 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
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