Clinical Trial Manager

This is an interesting new role for a candidate who likes to become part of an exciting project, someone who is self-motivated and has proven oversight and hands-on skills and a pioneering mindset to contribute to the success of biotech scale-up company. We are expanding the team and we are looking for an experienced 
  
 

CLINICAL TRIAL MANAGER 

As Clinical Trial Manager you will oversee the planning and operational execution of assigned clinical trials from trial synopsis stage to reporting, according to agreed timelines, budget, operational and quality standards. You report to our Director of Clinical Operations. You will become a member of the Clinical Operations team, which is a part of the Clinical Development Department. 
  
At Leyden Labs we want to deliver a future without the threat of respiratory viruses by developing accessible, self-administrable products, so people can take control and live their lives to the fullest by protecting themselves against catching infections and preventing transmission to others. We aim for the highest, think unconventionally and focus relentlessly on delivering the impossible. At Leyden Labs we are different, fast and focused. The Clinical Operations Team contributes to this mission by delivering innovative clinical trials fast and with high quality. 
  
We are currently busy planning and executing Phase 1  and 2 trials. These trials will be conducted in a fully outsourced model.  
 

This is what you’re going to do on a daily basis and these are your responsibilities: 

• Manage the operational trial related activities in close collaboration with other functions, to ensure all trial deliverables are met according to timelines, budget, quality standards and operational best practices 

• Manage the development of clinical trial protocols, submission dossiers, operational documents 

• Training and supporting the CRO personnel and other functions on trial protocol and related questions and serve as point of contact for managing and answering questions relating to trial procedures 

• Ensuring the set up and maintenance of the Trial Master File for assigned studies 

• Interacting with trial sites and study vendors to ensure smooth trial set up and excellence of study conduct, reviewing site performance, handling of protocol deviations, and more. 

More about you:

• Pro-active, self-starter
• Excellent communication skills in a multi-stakeholder environment
• Demonstrated leadership and problem-solving skills
• Fluency in English
• Currently residing in the Netherlands with EU work authorization
• Ability to travel international 15-20% of the time
• Ability to start in December

The team works a hybrid on-site schedule, and 3 days on-site in the office are required. Ideally our new colleague starts as soon as possible. But we are willing to wait for the best candidate, so we understand you have a notice period or already planned your annual leave.

We are an equal opportunity employer, and we firmly believe in the added value of a diverse and inclusive group of people with one common goal. We are looking for people who can make an impact and work on a purpose, together.

If the purpose of this role and our company ticked all the boxes for your next adventure, please hit the button and let me know you’re interested by sending me a short cover letter and your cv and I will get in touch within 5 working days to plan a first call.

Note to all agency recruiters: given the important work our employees do, I kindly request that you do not disturb them by approaching our people directly. I'd love to hear from you at jobs@leydenlabs.com