Study Manager

• The Study Manager (SM) has responsibility for all study management aspects of assigned studies of limited complexity (e.g. single country, small number of countries) or manage a unique part of a larger study (e.g. recruitment and retention)

• The Study Manager leads and manages the tactical execution of one or more clinical studies from study startup through database release and inspection readiness to ensure timely delivery of quality study data.

• The SM provides quality oversight to the Clinical Research Organization (CRO) and of the CRO

• SMs may also input to and support compilation of sections to Clinical Study Reports

• The SM will provide leadership to the teams in the setting of realistic recruitment targets and delivery milestones as the single point of accountability for detailed study start-up and monitoring plans and for delivery to the agreed plans

• The SM is a core member of the Study Team and will represent the CRO on matters of study execution

• The SM works with functional lines and directly with CRO line functions to resolve or triage site level issues Qualifications• Vaccines

• Experience working on global teams

• Experience with cross functional teams

• Knowledge of Sponsor role(s) in research

o Liaise between Sponsor/Colleagues and external researchers to provide end to end management and oversight for all states of research collaboration studies.

• Vendor management – vendor management plans, managing data transfers, timelines, reconcile funding, etc.

• Understanding of protocol development/study design

• Publication management

• Site/PI facing role

o Prescreening/vetting identified sponsors ( manage documents required from PIs such as CV, PI questionnaires, etc.

o Assist with due diligence and contracting with sponsors (budget negotiations and contracts ensuring all documents are completed and uploaded into system)

• Managing multiple projects simultaneously

• Managing teams with broad responsibilities or from multiple functional areas

• Flexibility and willingness to learn 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.