Will lead cross-functional study team responsible for global execution of large, complex clinical trials from study design through study close-out.

Key Responsibilities:

• Development of study specific documentation, e.g. case report forms (CRF), data management plan, monitoring plan, monitoring oversight plan, project specific training plan, data review plan, statistical analysis plan, etc.
• Supervise, set-up and maintain study systems such as Clinical Trial Management System (CTMS), Trial Master File (TMF) etc.
• Manage feasibility assessment to select relevant regions and countries for study
• Directly supervise Clinical Trial Management staff

Experience:

• Direct management experience with demonstrated results building and developing outstanding teams along with the capacity to understand and implement the strategic direction and guidance for respective clinical studies
• Managing 3rd Party Vendors
• Minimum bachelors degree
• Minimum 8 years industry experience
• Direct experience managing global clinical trial operations