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.
In direct collaboration with our pharmaceutical client we have a newly open Manager of Monitoring role in Johannesburg, South Africa. This is a full time, office based role.
Manager of Monitoring is responsible for leading and managing a group of CRAs within the local Monitoring & Site Management organization for applicable Phase II-IV Global Development clinical trials. As the manager of this group, Manager of Monitoring is accountable for ensuring direct reports are managing all monitoring and site management related activities from Feasibility to Site Selection to Clean Database to Site Archive, to ensure study execution is on track.
Manager of Monitoring is accountable for quality oversight of direct reports and ensuring each deliver on commitments and expectations, as well as holding direct reports accountable their commitments and expectations. The Manager of Monitoring, will ensure that team members are appropriately resourced to balance training and development, study activities, quality and other responsibilities sufficiently.
Due to the increased scrutiny of regulatory authorities on the quality of clinical trial data, and increased business demands to conduct clinical trials in an efficient manner, the focus of the Manager of Monitoring position is strengthened to reflect greater focus on quality and oversight.The manager of Monitoring will work directly with the Sponsor Country head and will report directly to the PRA Line Manager.
The incumbent must have a Bachelor’s Life Science degree (or equivalent) with proven track record of relevant healthcare experience including years of clinical monitoring and site management experience. In-depth knowledge of clinical development and drug development process, Global Monitoring and Site Management processes, ICH-GCP, applicable legal, compliance and regulatory requirements. Leadership, motivational, and interpersonal skills are critical.
The incumbent must possess the ability to lead staff in changing times as well as strong interpersonal skills in the management and development of people in a global environment. Administrative, financial, and technical skills are required, as well as effective verbal and written English and Afrikaans communication skills in relation to both internal and external colleagues.
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.