Clinical Trial Coordinator

4 weeks ago

Cambridge, Cambridgeshire, United Kingdom MoonLake Immunotherapeutics Full time
Job Summary

We are seeking a highly organized and detail-oriented Clinical Trial Administrator to provide administrative support and maintain essential clinical documentation for our sponsored clinical studies.

Key Responsibilities
  • Provide document management and filing support, including preparation of document review forms, protection of files, tracking and issue of key documents, and performance of file reviews.
  • Assist with setting up and attending internal meetings, such as Clinical Development Oversight Team meetings and Clinical Operations meetings, and prepare minutes as required.
  • Work closely with Clinical Operation Managers to set up internal SharePoint oversight files for each study and support development teams with filing as needed.
  • Assist with providing MoonLake documents needed in the eTMF and carry out QC and completeness checking throughout the study.
  • Perform clinical trial-related administrative tasks, including tracking study activities, plans, and key study dates, maintaining logs and lists, and providing support to Clinical Operations Managers as required.
  • Assist with managing MoonLake's Clinical Trial public registries accounts and ensure public disclosure requirements are met through timely updates.
  • Provide general administrative support for the Clinical Development Team within MoonLake.
Requirements
  • Higher qualification in life science or nursing or other healthcare-related subject or proven track record of on-the-job training gained in similar roles within the pharmaceutical industry.
  • Experience of clinical trials as a clinical trial administrator or clinical trial coordinator, with working knowledge of regulated environments and operating to quality systems, and working knowledge of Good Clinical Practice regulations.
  • Excellent written communication skills, with the ability to follow meetings involving significant scientific content and summarize accurately and concisely.
  • Excellent computer skills, with the ability to use standard office packages and clinical trial-related systems, where required.
  • Highly organized, with the ability to prioritize effectively and work well under pressure.
  • Completer/finisher with a strong sense of order, attention to detail, and pride in their work.
About Us

MoonLake Immunotherapeutics is a clinical-stage biopharmaceutical company unlocking the potential of sonelokimab, a novel investigational Nanobody for the treatment of inflammatory diseases, to revolutionize outcomes for patients.

We continue to make significant progress in our Global Clinical Development Programs, focusing on inflammatory diseases with a major unmet need, including hidradenitis suppurativa and psoriatic arthritis – conditions affecting millions of people worldwide with a large need for improved treatment options.

MoonLake was founded in 2021 and is headquartered in Zug, with hubs in Cambridge & Porto.

Further information is available at www.moonlaketx.com

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