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 https://www.genmab.com.
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