Do you want to be part of a dynamic team, working in an international environment that drives clinical trial activities? Are you structured and have good planning skills? Do you have a passion for administrative and coordinating tasks and provide support to vendors and stakeholders? Then we may have just the right job for you! In Clinical Drug Development, Clinical Operations, we are looking for a new colleague to join as Senior Clinical Trial Administrator.
The Position
As Senior Clinical Trial Administrator you will be an essential member of the trial management team supporting the clinical trial planning, execution, and finalization by performing administrative tasks as well as wide communication with international stakeholders and collaborators.
By use of your structured approach and high-quality mindset, you will take ownership in establishing and maintaining the Trial Master Files in accordance with standard operational procedures (SOP) including uploading and updating of information, indexing and Quality Control of trial documents in our different IT Clinical systems.
As a Senior Clinical Trial Administrator, you will set up virtual international meetings on Microsoft Teams as well as face-to-face meetings and maintain our document sharing platforms used by the trial team members for sharing trial related documents with external vendors and collaborators, prepare newsletters and PowerPoint presentations.
You will be highly involved in outsourcing processes, trial budgets and you will be involved in the preparation of clinical documents, plans, manuals, and enrollment updates. All activities are carried out in close collaboration with the trial responsible trial managers.
Qualifications
To be successful in this role, you should have:
• Broad administrative experience within the pharmaceutical industry.
• Proficiency in written and spoken English.
• Strong IT skills, including MS Office (Excel, PowerPoint, Teams).
• Knowledge and experience with Trial Master File systems.
• Understanding of basic project management principles.
• Experience working with CROs and outsourced activities is an advantage.
In addition, our ideal candidate is a team player who can work independently, has excellent organizational skills, and pays attention to detail. You should be able to manage deadlines and prioritize tasks effectively. Good collaboration skills and a sense of humor are also important.
About the area
Rare disease isn’t so rare. Collectively they affect over 30 million people in Europe and around 350 million people across the globe. Although there are more than 7,000 different rare diseases, most of them share similar characteristics: they are often chronic, lifelong genetic conditions (72%) with childhood onset (70%) and no cure. They result in decreased quality of life and typically a reduced life expectancy. At the same time there is diagnostic delay, lack of coordination of care and variable patient access to treatment depending on where they live.
In our project area we cover the entire spectrum of clinical development activities within Rare Endocrine Disorder, Rare Blood Disorder and Rare Bleeding Disorder from early phase 1 trials to large phase 3a programs and phase 3b/4 life cycle management activities on our marketed products.
This position is in Clinical Operations, Rare Blood Disorders within the indication of Sickle Cell disease and Thalassemia.
Clinical Operations is responsible for the set-up and execution of phase 1-4 clinical trials within the area. Our environment is characterized by a vast global network, knowledge sharing, talented colleagues and challenging assignments in a dynamic project centric organization. We offer continuous personal and professional development opportunities as being part of a large headquarter function.
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