Study Start Up Lead

Description

As a top five CRO, we have worked on 100+ marketed drugs across many therapeutic areas and have conducted the pivotal or supportive trials that led to FDA and/or international regulatory approval of 45+ such drugs.

At PRA Health Sciences, providing innovative solutions for our clients is what we do. From full service clinical development to the pioneering Embedded SolutionsTM model, PRA provides a broad spectrum of solutions that meet the demands of a diverse marketplace.

At PRA, borders do not create boundaries. PRA's success is dependent upon our ability to attract and retain a talented team of diverse professionals. Our growing workforce is comprised of over 10,000 employees, spanning 13 time zones across six continents and who speak more than 30 languages - yet operate in unison as one worldwide PRA community.

As a member of the Clinical Operations team, you will be responsible for all aspects of Start Up activities at the regional level to achieve quick and successful activation of sites in accordance with ICH GCP, FDA regulations, applicable regulations and requirements, and SOPs. You will be working on a wide spectrum of projects in phase I-IV research at both GP practices and hospitals. Responsibilities will include: using the start-up methodology to drive early and predictable site activations through oversight of all regulatory, clinical and site contract activities, working collaboratively with functional colleagues and Sponsors, eliminating all potential causes of delay, overseeing compliance, and reporting progress.