Clinical Trial Associate

at  Leyden Labs

In our Clinical Operations team and we are looking for an experienced

CLINICAL TRIAL ASSOCIATE

to join our growing team and work from our office in Leiden.
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:

As our CTA, you

• will assist the Clinical Trial Teams in ensuring the most effective and efficient conduct of clinical trials by providing administration and project tracking support, including eTMF maintenance.
• play an instrumental role by supporting the preparation, handling, distribution, collection and archiving of clinical documents and reports, including contracts and invoices.
• are responsible for ensuring that all current files are periodically reviewed for completeness.
• assist with generating meeting minutes or status updates regarding project correspondence
• interface with internal colleagues and external vendors.
• work closely with the Clinical Trial Manager to establish a high-quality environment
• You hold a Master’s degree in a life science related field
• At least 2 years’ experience in a CTA role in a bio-pharmaceutical and/or CRO environment
• Proven training in/knowledge of GCP and International Conference on Harmonization (ICH) Guidelines
• Previous experience working with eTMF, EDC, CTMS systems
• Ability to independently manage documentation and team support needs
• Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint

More about you:

• Pro-active, self-starter
• Meticulous
• Effective time management and organizational skills
• Excellent communication skills in a multi-stakeholder environment
• Excellent verbal and written communication skills in English
• Currently residing in the Netherlands with EU work authorization
• Available for 40 hours per week

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

Please refer the Job description for details