Job Purpose
As a Clinical Trial Administrator you will provide administrative support and maintain essential clinical documentation for MoonLake sponsored clinical studies.
Key Accountabilities:
* Provide document management and filing support for MoonLake Clinical Development Projects including preparation of document review forms, protection of files, tracking and issue of key documents and performance of file re-views.
* Assist with set up, and attend and prepare minutes of internal meetings e.g. regular Clinical Development Oversight Team meetings, Clinical Operations meetings etc.
* Work closely with the Clinical Operation Managers to set up the internal SharePoint oversight files for each study and support development team with filing as required.
* Assist with providing MoonLake documents needed in the eTMF, and carry out QC and completeness checking throughout the study.
* Carry out 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 management of MoonLake's Clinical Trial public registries accounts and ensure public disclosure requirements are met through timely updates.
* Provide general administrative support for Clinical Development Team within MoonLake
Your profile
Education: Higher qualification in life science or nursing or other healthcare related subject or proven track record of on-the-job training gained in similar role(s) within the pharmaceutical industry
Experience: Experience of clinical trials as a clinical trial administrator or clinical trial coordinator. Sr Clinical Trial Admin, working knowledge of regulated environments and operating to quality systems, working knowledge of Good Clinical Practice regulations.
Skills/knowledge/behavioural competencies:
* Excellent written communication – must be able to follow meetings involving significant scientific content and summarise accurately and concisely
* Excellent computer skills, ability to use standard office packages and clinical trial related systems, where required.
* Must be highly organised, able to prioritise effectively and work well under pressure.
* Completer/finisher with strong sense of order, attention to detail and pride in their work.
Work Location:
* 2 days a week in our brand new Cambridge or Porto office.
Why us?
An exciting job opportunity awaits you
MoonLake is a dynamic and innovative company pushing the boundaries of possibility, and we are looking for passionate individuals to join our stellar team.
What we offer:
Learning Environment: An opportunity to learn and grow alongside experienced professionals in a supportive and innovative biotech environment.
Impactful Work: Contribute to ground-breaking projects that have the potential to transform global healthcare.
Flexibility and Balance: Work remotely/hybrid, enjoying a healthy work-life balance while making meaningful contributions to our team.
Career Growth: A clear path for career progression, with the chance to take on more responsibilities as you develop your skills.
Our Core Values
We look for potential MoonLakers that embody our three core values that drive our pursuit of excellence:
We do Stellar Science: We aspire to create novel therapies that elevate treatment horizons, with innovative science, and high quality, always.
We go beyond: We aspire to be positively disruptive in our field, and bold in the way we challenge the norms and each other.
We unlock value: We aspire to create long-term value for investors and communities.