Experience: 2 years

Job Description:

• Act as primary sponsor contact for endpoint Adjudication issues/ information for full-service projects and ensure on time and on budget performance for related work.
• Act as project manager for stand-alone Endpoint Adjudication projects
• Act as liaison among other functional areas within the sponsor company and throughout Syneos Health.
• Understand and manage project budget and contracts as well as any updates or revision that are required.
• Maintain an up to date awareness of team resources needs and availability and provide accurate updates as required.
• Evaluate Endpoint Adjudication team metrics, identify areas of potential issues, implement plans to improve efficiency and measure and report outcomes of improvement actions.
• Assist in the creation and documentation of new or revised departmental procedures and guidelines.
• Manage to the required level of quality the timely completion and delivery of assigned Endpoint Adjudication tasks.
• Develop study-specific endpoint, event reporting and review, and adjudication processes.
• Oversee the development of forms and tracking reports required for the execution of endpoint event reporting and review/ adjudication process.
• Present at investigators meetings and CRA trainings and study launch meetings.
• Plan, coordinate logistic for and facilitate Clinical Event committee meetings.
• Review Adverse Event (AE)/ Serious Adverse Event (SAE) and other data listing and provide appropriate follow-up with the investigator site to ensure that all potential endpoint or events have been reported.
• Review and approve monthly client and vendor invoices
• Prepare project management reports for clients, project personnel and Syneos Health management.
• Contribute to reports or publications related to Endpoint Adjudication
• Training staff on processes, internal procedures and endpoint query reports.
• Mentor staff on project procedures and policies and mentor direct reports
• Provide oversight of day to day task of team members
• Participate in user acceptance testing (UAT) for electronic systems
• Review tables and listing generate from study data
• Develop study specific tools for tracking and reporting for the team
• Develop and write Endpoint Adjudication plans.
• May assist in the creation of Business Development proposals by contributing Endpoint Adjudication related information and costs.
• May participate in bid defense meetings as required.