PRAHS 2016-37307 in United States
As a top five CRO, we have worked on 100+ marketed drugs across several therapeutic areas and 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.
Working fully outsourced at one of our global pharmaceutical clients, The Country Lead Monitor (CLM) will manage and coordinate the cross-functional Country Feasibility team and process, involving the local Monitoring and Site Management team. Taking ownership of two or more projects, the CLM ensures all study sites are initiated according to planned study time lines, manages and tracks the Study Country Level Budget, providing monthly country budget information to Local Controlling and Study Manager. The CLM also ensures all country CRAs are trained sufficiently for the trial, Identifies training gaps if additional training is required at country level and works with the Study Lead Monitor to develop further training plans. This role does involve frequent monitoring alongside these additional local study oversight duties. We can consider Senior CRA's for this position, particular those who have undertaken Lead CRA and Trial management duties within the role.
A minimum of a BA/BS degree is required, preferably in a health or science related field. Specific therapeutic area experience may be required depending on the position.Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.Willingness to travel with occasional overnight stay away from home.Some previous experience of lead CRA or local study management experience is preferred. Proficient in speaking and writing English Good written and oral communication skills.