CST Project Manager (eCOA Manager) ** Remote SERBIA **

Syneos Health is a fully integrated life sciences services organization supporting drug development and commercialization. The CST Project Manager manages Clinical Surveillance & Training scoped services for clinical trials, coordinating customers, vendors, investigative sites, project deliverables, documentation, risks, resources, and quality from study start-up through final delivery.

Responsibilities:

• Working under the limited guidance and mentorship of the CST Director BU Ops, Management (Line Manager) or designee:
• 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, including 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
• Train and mentor internal team members

Requirements:

• 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
• Bachelor's Degree (or equivalent) level of qualification in Life Sciences, Medicine, Pharmacy, Nursing or related field equivalent preferred
• Prior experience in study coordination, contract research organization (CRO), pharmaceutical, biotechnology or rater training vendor company preferred