Clinical Study Manager

Position Title:  Clinical Study Manager

 

Reports to:  Head of U.S. Clinical Development

 

Function: 

 

The Clinical Study Manager will work with the scientific/medical lead to manage operations for clinical research efforts on one or more compounds within a matrix organization. While the candidate will be responsible for studies conducted in North America, we are a global company and the job will be international in scope.

 

We are in the process of expanding our efforts in the United States. If you like the idea of a ?small company? within a ?large company?, we may have a place for you to gain international experience, enjoy professional growth and participate in our success!

 

Specific responsibilities will include:

 Operational planning and coordination of one or more clinical studiesCoordination of internal study team and external partners e.g., Contract Research Organizations (CROs) and investigational site personnelOversight and training of project Clinical Research Associates (CRAs)Selection and contracting of CROsSelection and contracting of study sites Planning and tracking budgets, resources and study timelinesInsure adequate study documentation and archivingInsuring cGCP compliance by internal and external team membersPerform co-monitoring as neededAssist in protocol and case report form design

 

 

Requirements:

 Bachelor?s degree required, higher degree in scientific or medical area desirableAt least 5 years of pharmaceutical experience in clinical operations including monitoring and study managementExcellent verbal and written skills. Some knowledge of German would be beneficial but is not required.Development experience in the area of pain and analgesicsSolid understanding of project management and experience interacting with functions such as data management, regulatory, drug safety and medical writing.Solid understanding of budgeting and financial trackingSome overnight and international travel is requiredAn enthusiastic, ?can-do? attitude is essential