Peter Jongste Email & Phone Number

Leiden, Zh, Nl

Leiden, Zh, Nl

As a Regulatory Affairs Associate at ICON, I am responsible for preparing and submitting clinical trial applications and managing life-cycle submissions under CTD and EU-CTR for clinical trials in the Netherlands. My key responsibilities are:- Creating country-specific documents, such as ICFs and CTR-specific country documents- Creating submission packages according to the Dutch standard research file and submitting these to the Ethics Committees and Regulatory Authority (CTD)- Creating part II submissions and supporting with part I submissions (CTR)- Maintaining the CTMS by planning and tracking regulatory submissions- Maintaining the eTMF with regulatory documents

Contract and Relationship management of outsourced work.Part of various process improvement projects using Lean and other tools.

Internship project on process design using Lean Six Sigma to design a process within the department on investigating incongruent data

Leiden, Zuid-Holland, Nederland

Department of dermatology - Multispectral three-dimensional imaging as a possible tool for the clinical quantification of cutaneous warts

Leiden, Zuid-Holland, Nederland

The EL CID-week is the official introduction week of Leiden University, offering over 3,500 new students the opportunity to explore the city, their new studies and everything to do with what its like being a student. My main tasks as an acquisitor included contacting and collaborating with companies, finding innovative opportunities to link new students to companies and organising the introduction week together with a team of 5 others.

Leiden, Zuid-Holland, Nederland

Master, Bio-Pharmaceutical Sciences

Bachelor Of Science - Bsc, Bio-Farmaceutische Wetenschappen