Senior Clinical Project Manager

at Pharming Healthcare in Boise, Idaho, United States

Senior Clinical Project Manager

About Pharming

Pharming Healthcare Inc. is a global biopharmaceutical company dedicated to transforming the lives of patients with rare, debilitating, and life-threatening diseases. We are developing and commercializing a portfolio of innovative medicines, including small molecules and biologics. Pharming is headquartered in Leiden, the Netherlands.

Our Vision

Our Vision is to develop a leading global rare disease company with a diverse portfolio and presence in large markets, leveraging proven and efficient clinical development, supply chain, and commercial infrastructure.

Life at Pharming

Today, more than ever, were positioned to realize our vision of becoming a leading global rare disease company. Our success will come from everyones commitment to our patients, our ability to work with focus and clarity, and our shared dedication to building something meaningful together. We can only achieve this by embracing our biotech culture, Life at Pharming, which is dynamic, experimental, and shaped by what we learn together.

Summary

The Senior Clinical Project Manager (Sr. CPM ) is responsible to plan, initiate, execute and report assigned clinical studies in accordance with the study protocol, ICH - GCP guidelines, SOPs and other relevant laws and regulations. The Sr. CPM selects, guides, and supervises third party vendors and defines budgets, timelines, and resources for the assigned clinical studies. The person in this position implements effective training and guidance of study team interactions, study sites and external contributors throughout the course of a trial. This needs to be executed in close cooperation and transparent communication with cross-functional teams such as: Clinical study team, Pharmacovigilance, Supply Chain, Regulatory Affairs, Quality Assurance requiring a huge ability to coordinate multiple, parallel processes in order to oversee and control a successful course.

Responsibilities

Clinical Studies

+ Coordinate with cross-functional teams during the clinical study development phase to ensure there are appropriate internal resources, IMP and sufficient budget for the conduct of the clinical study

+ Oversee project level operational aspects of the clinical study, including development and management of study timelines, budget and deliverables

+ Lead the selection, contracting and budget negotiations of CROs, other third-party vendors and clinical trial sites

+ Plan and