CST (eCOA) Project Manager

Syneos Health is a leading fully-integrated life sciences services organization that accelerates customer success in drug development and commercialization. The CST (eCOA) Project Manager will manage CST deliverables, interact with various stakeholders, and ensure quality and timely delivery of services for clinical studies.

Responsibilities:

• Function as a representative of the Clinical Surveillance & Training (CST) team on small to large-sized studies or programs, interact with other functional groups, vendors, license holders, Key Opinion Leaders (KOLs), and Sponsors. May serve as a Project Lead in CST stand-alone projects and serves as a Functional Lead in full scope or multiple protocol projects
• Manage CST deliverables pertaining to scoped services, vendors (i.e., Rater Training vendors), scale license holders, and/or KOLs
• Manage all aspects of license procurement, scale translation requirements, and paper scale worksheet development
• Manage creation of all CST service-related documentation and templates. This may include managing development and testing of the CST Study Training and Engagement Portal (STEP) to meet study-specific Rater Training needs
• Manage all aspects of CST services to ensure quality and timely delivery and implementation
• Develop and maintain the study-specific CST Plan in accordance with Standard Operating Procedures (SOPs) and Work Instructions (WIs)
• Contribute to relevant functional project plans to ensure alignment with the CST Plan
• Provide regular and timely status updates to internal and Sponsor project teams regarding CST scoped services, including risks to delivery such as timeline delays and serve as a central point of contact for CST-related project issues and solicit support from LM or CST SMEs, as required
• Create and maintain CST metric reports for scoped services, for delivery to client
• Attend Trusted Process, internal and Sponsor meetings as a lead CST representative to discuss CST strategy, address CST-related agenda topics, and provide status reports
• Ensure CST project documentation is maintained on an ongoing basis and ensure required documentation is filed completely and accurately in the Trial Master File (TMF)
• Identify risks and develop mitigation plan as required
• Participate in Sponsor, internal or agency audits and inspections, as required
• Responsible for management of CST scope, including identification of CST out of scope activities and overburn, revenue recognition (if delegated this task by study lead or if serving as a Project Lead in stand-alone study), invoice management (tracking and confirmation of payment), and/or KOL contract and management, etc. May participate in internal financial review meetings to review CST overburn or financial risk, as needed
• Plan, manage, and request CST resources (e.g., CST Project Specialist, CST Clinical Scientist, CST Assessment Scientist, etc) and provide CST resource updates for assigned projects

Requirements:

• Function as a representative of the Clinical Surveillance & Training (CST) team on small to large-sized studies or programs
• Interact with other functional groups, vendors, license holders, Key Opinion Leaders (KOLs), and Sponsors
• May serve as a Project Lead in CST stand-alone projects and serves as a Functional Lead in full scope or multiple protocol projects
• Manage CST deliverables pertaining to scoped services, vendors (i.e., Rater Training vendors), scale license holders, and/or KOLs
• Manage all aspects of license procurement, scale translation requirements, and paper scale worksheet development
• Manage creation of all CST service-related documentation and templates
• Manage development and testing of the CST Study Training and Engagement Portal (STEP) to meet study-specific Rater Training needs
• Manage all aspects of CST services to ensure quality and timely delivery and implementation
• Develop and maintain the study-specific CST Plan in accordance with Standard Operating Procedures (SOPs) and Work Instructions (WIs)
• Contribute to relevant functional project plans to ensure alignment with the CST Plan
• Provide regular and timely status updates to internal and Sponsor project teams regarding CST scoped services
• Serve as a central point of contact for CST-related project issues and solicit support from LM or CST SMEs, as required
• Create and maintain CST metric reports for scoped services, for delivery to client
• Attend Trusted Process, internal and Sponsor meetings as a lead CST representative
• Ensure CST project documentation is maintained on an ongoing basis
• Ensure required documentation is filed completely and accurately in the Trial Master File (TMF)
• Identify risks and develop mitigation plan as required
• Participate in Sponsor, internal or agency audits and inspections, as required
• Responsible for management of CST scope, including identification of CST out of scope activities and overburn
• Manage revenue recognition (if delegated this task by study lead or if serving as a Project Lead in stand-alone study)
• Manage invoice management (tracking and confirmation of payment), and/or KOL contract and management
• Plan, manage, and request CST resources (e.g., CST Project Specialist, CST Clinical Scientist, CST Assessment Scientist, etc)
• Provide CST resource updates for assigned projects