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Operational Study Manager - Real World Solutions in Blue Bell, PA

PRA Health Sciences

Blue Bell, PA 19422
7w ago



Life Sciences


Less than 5 years

Job Description

Achieves successful delivery of operational activities (site management, clinical monitoring, and/or data review) by meeting internal and external client requirements. Oversees the management of physician sites to ensure compliance with the protocol, ICH-GCP, other relevant guidelines (such as ISPE GPP) and applicable regulations, as well as SOPs. Contributes to Business Development Activities by participating in proposals and bid defenses as required. Along with the OSM (Operational Study Manager) role on a project, may function in a PM role with mentoring and supervision.



  • Ability to understand the big picture – the scientific goal of their project, how the study design relates to that, why the client is doing the research, what the regulatory requirements will be for a particular study (in late phase, this does vary more than in PR), independent problem solving to make sure timelines are met, assessin
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Valid through: 2020-2-18

About PRA Health Sciences

PRA Health Sciences is a Contract Research Organization with headquarters in Raleigh, North Carolina, USA. The organization has worked on 100+ drugs marketed across several therapeutic areas and conducted the pivotal or supportive trials that led to U.S. Food and Drug Administration (FDA) and/or international regulatory approval of 50+ such drugs. PRA was founded in 1976 as the Anti-Inflammatory Drug Study Group in Charlottesville, Virginia, USA. Renamed PRA in 1982, it established itself as a data-management Contract Research Organization (CRO). After a number of strategic decisions to enhance its service offerings, the company became PRA Health Sciences in June 2014, incorporating partnerships and acquisitions made throughout 2012 and 2013. Key dates:
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