CST Project Manager

Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. The CST Project Manager will manage CST deliverables, collaborate with various stakeholders, and ensure the quality and timely delivery of services in 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, eCOA vendors, etc), 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 eCOA vendor timelines, deliverables and budget, including participation in eCOA vendor meetings (i.e. eCOA vendor KOM)
• 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
• Engagement with Clinical Data Sciences (CDS) on Clinical Outcome Assessments (COA) data collection strategy, including integration, and facilitate data transfer agreement
• Lead requirements gathering and specification development and finalization with eCOA vendor
• Collaborate with the CST Scientist in the development and execution of UAT test scripts per eCOA system configuration; manage, track and follow up cross-functional UAT outcomes through completion
• 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
• Prepare and distribute CST internal meeting agenda, minutes, and action items
• 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 filed and maintained on an ongoing basis 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 and/or eCOA vendor 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 Clinical Scientist, CST Assessment Scientist, etc) and provide CST resource updates for assigned projects
• Track and follow up of all CST service specific activity
• Maintain timely and effective communication with site staff to ensure timely compliance with training and documentation requirements

Requirements:

• Bachelor's Degree (or equivalent) level of qualification in Life Sciences, Medicine, Pharmacy, Nursing or related field equivalent preferred
• Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince and persuade
• Good organizational, planning, customer service, and time management skills with the ability to multitask under tight deadlines while providing attention to detail. Ability to manage time and work independently
• High level of competency in English language
• Proficiency with MS Office Applications
• Strong knowledge of Good Clinical Practice (GCP)/ International Conference on Harmonization (ICH) guidelines and other applicable regulatory requirements
• Prior experience in study coordination, contract research organization (CRO), pharmaceutical, biotechnology or rater training vendor company preferred