People living with a rare disease are at the center of everything we do at PSR. We focus on the patient, and how to make a positive impact on the lives of these patients with a rare disease. The experts at PSR want to deliver a good job, with a lasting impact: for ourselves personally and for the company or patients we commit ourselves to. To achieve this, we take our responsibility and ensure that everyone can make the very most of their unique talents. At the moment we are 65 PSR Orphan Experts strong, of whom 30 work at PSR’s office in Hoofddorp, the Netherlands. Circa 30 freelance CRA’s are home-based across Europe and 7 PSR employees are outsourced. 

The Project Manager is fully responsible for the coordination of clinical trials in orphan drug development. Your custuomer is the sponsor, you should organize your tasks in the best way to meet the expectations of the customer. Your activities will include (but not limited to): 

• Regular liaison with sponsor and study team members;
• Providing adequate training, guidance and tools to study team;
• Managing progress of the study;
• Managing study budgets;
• Identifying and solving any study-related issues.

The ideal candidate: 

• Master degree in scientific, health care, life sciences or (para)medical area;
• At least 5 years of clinical project management experience;
• Experience with Orphan Drug studies;
• Familiar with leading an international study team;
• Fluent in English (written and spoken) and you speak Dutch well enough to tell a good joke;
• In-depth knowledge of Good Clinical Practice (GCP) and local regulations and processes;
• You are stress-resilient, have a positive attitude and are fun to work with.

PSR is part of the Ergomed group. We joined forces together to create a leading orphan drug development expert team that will allow our clients to implement patient driven solutions in their clinical trials. Rare disease clinical trials are not just smaller versions of conventional clinical trials and therefore require an innovative approach. By combining Ergomed’s global reach and site management model with PSR’s specialized focus on orphan drug development, we will continue to improve the lives of patients and their families impacted by rare diseases across the world. The office in Hoofddorp is an inspirational and growing international work environment in wich you can show that things can be done differently and you will get challanged.