• Select and manage vendor selection

• Hire and manage sponsor study team

• Manage completion and execution of clinical trial protocol

• Select and oversee sites

• Build site relationships

• Manage subject recruitment

• Ensure data quality, manage completion and reporting of studies

 

CLINICAL OPERATIONS INFRASTRUCTURE TO SUPPORT PHASE III

• Continued development of SOPs, forms, tools and templates

• Management of Clinical Trial Management Systems

• Support resourcing for Phase III

• Develop/deliver targeted training to team

• Manage pre-submission Quality Assurance Auditing Program

 

PROGRAM MANAGEMENT

• Manage alliances as required

• Support competitive intelligence and pipeline analysis