Project Manager Clinical Operations

Project Manager Clinical Operations (m/f)

The Clinical Operations department in Leiden is looking for a Project manager Clinical Operations to strengthen its team. As a Project manager Clinical Operations you are responsible for the provision of the required information for the clinical part of the registration dossier for a designated product. You will also occupy yourself with the coordination/managing of the preparation, initiation, execution and reporting of clinical trials (in- and outsourced) concerning the assigned product within budget and timelines. You will make sure that this happens in accordance with the study protocol, ICH-GCP regulations, SOP’s and other relevant laws and regulations. You will work under the supervision of the Director Clinical Operations.

Profile:
The person we seek:
• Has academic work/thinking skills and an education in biopharmaceutical sciences or a comparable discipline;
• Has excellent knowledge of ICH-GCP;
• Has knowledge of project management;
• Has at least five years experience in project management of clinical trials, preferably in the biopharmaceutical industry (experience with monitoring is required);
• Has a proactive attitude (amongst other things is alert on relevant scientific developments and is capable of translating these into strategic proposals or ideas);
• Has good negotiation skills;
• Is capable of leading (a project team);
• Has a great sense of responsibility;
• Is focused on results;
• Is accurate;
• Is flexibel;
• Is decisive;
• Is a good teamplayer;
• Has knowledge of the standard Office packet;
• Has good organizing and planning skills;
• Has excellent communication skills,
• Is competent in Dutch and English language, both orally and in written.