The companyOur client is a professional Pharmaceutical and Biotechnology organisation, based in Utrecht Netherlands. Sire has been retained to exclusively recruit for a Project Clinical Trial Coordinator for AM-Pharma.
AM-Pharma is a clinical-stage biopharmaceutical company developing proprietary recombinant human Alkaline Phosphatase (AP) therapeutics. Its most advanced asset, known as recAP, is a fully human recombinant form of AP.
AM-Pharma has completed its STOP-AKI adaptive Phase II study in 301 sepsis patients with AKI, the largest therapeutic study in AKI to date in 2018. The study demonstrated a significant relative reduction in mortality of more than 40% in the treatment group compared to the placebo group, and a long-term improvement in kidney function. Throughout the study, recAP was shown to be safe and well tolerated.
To support regulatory approval from the US Federal Drug Association (FDA) and European Medicines Agency (EMA), a Phase III pivotal study will be conducted. To support this, SIRE is currently looking for a Project Clinical Trial Coordinator.
Role descriptionAs a Project Clinical Trial Coordinator at AM-Pharma, you will be play a pivotal role in bringing to market this potential life-saving medical treatment. You will have the opportunity to work with a collaborative and successful team to support our Clinical Trial Management and Project Management teams with operational activities. We pride ourselves on our amazing company culture, where we work as one team to achieve industry-leading results.
Reporting into the VP of Clinical Operations, you will:
• Provide technical support to the project team
• Coordinate non-clinical responsibilities of project administration as applicable to the client contract under the direction of the project manager/VP of Clinical Operations
• Reviews regulatory documents for proper content
• Coordinates teleconferences and creates meeting agendas
• Distribution of meeting minutes and finalization of minutes
• Create/ Set-up Trial Master File
• Maintain and Track clinical study documentation under GDP
• Proficient English language skills
• Strong interpersonal skills and high attention for detail, with ability to handle multiple tasks efficiently and effectively
• Good communication skills with ability to work in small team environment
• Previous administration experience in clinical research preferable with desire to grow
• Ability to analyze documents, project specific data and systems for accuracy and efficiency
Other informationCompany Culture
The company culture of AM-Pharma is built on four important competences: Collaboration, Quality orientation, Accountability and Resilience. At AM-Pharma we work together in a constructive, collaborative and team-oriented way, towards achieving the company objectives without losing sight of our own objectives. We put the common interest of the company above our own individual interest.
We set high standards regarding the quality of our materials, processes, documentation and collaborations, the staff are motivated to deliver excellence whilst also working to continually improve the quality of our work. We are fully accountable for the things that are in our power and control while working on the goals of the organization. We have an obligation to proactively report, explain and justify the things we do. We accept responsibility for our performance and we are transparent about the results of our work. Finally, we understand how to cope effectively with setbacks and obstacles and overcome hurdles on our way to reach our common goal. We stay committed to agreed objectives and company culture despite resistance while having the strength to adjust our plans when necessary. We are tolerant to stress and we deal effectively with criticism and resistance, building on our own strength.
As of year-start 2020, AM-Pharma will be based in the World Trade Center Utrecht, located next to Utrecht Central train station.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Iselde van Beurden.