FSP - Protocol Operations Lead (Remote)

The Protocol Operations Lead (POL), using project management and leadership skills, is responsible for the operational delivery of one or more Non-Interventional (NI) Studies from study concept through to reporting and study close out in alignment agreed timeline, cost and quality goals through the matrix leadership of the Study Team(s) The POL may also contribute to audits/inspections as appropriate The POL is the primary point of contact between the Business Unit (BU) (including clinical and Outcomes) and Development Operations (Dev Ops) at the study level The POL will oversee operational delivery, through an external Clinical Research Organization (CRO) where the operational activities are fully outsourced (these studies will fall outside the Alliance Partner model) The POL leads the Study Team operations and project manages study deliverables through internal (within Development Operations, business unit and other platform lines) and external resources and is the primary point of contact and interface between these functional groups QualificationsBachelor’s degree or equivalent in one of the disciplines related to life sciences, drug development, project management or business Knowledge and success in managing multiple clinical studies Demonstrated knowledge of clinical development and requirements Knowledge of Data Management processes, data acquisition and management technologies and processes Demonstrated ability to manage projects and processes Proven track record of effective project management of drug development or other projects in a highly matrixed environment Required to deliver, time, and cost, quality and risk management to teams Understands and has demonstrated the ability to manage large and complex budget; history of staying on or under budget Knowledge of team development principles and successful implementation Leadership, project management, resource management, administrative and technical capabilities Experience in managing fully outsourced projects or vendor oversight is highly desired for this position Extensive clinical operations and pharmaceutical business experience in order to have a thorough understanding of the processes associated with executing clinical development plans and addressing related regulatory issues is preferred Effective verbal and written communication skills are required in relating to customers and colleagues both inside and outside the organization is preferred Experience with alliance partnerships is beneficial EEO DisclaimerParexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.