CST Project Manager – eCOA Manager

• Provide customer-focused management of Clinical Surveillance & Training (CST) scoped services to support scientific integrity and data quality in clinical trials
• Liaise with customers, vendors, and investigative sites from project start-up through final deliverables
• Represent the CST team on small to large-sized studies or programs
• Interact with functional groups, vendors, license holders, Key Opinion Leaders, and Sponsors
• Serve as Project Lead in CST stand-alone projects and Functional Lead in full-scope or multiple-protocol projects
• Manage CST deliverables, license procurement, scale translation requirements, and paper scale worksheet development
• Manage CST service documentation, templates, and the Study Training and Engagement Portal
• Ensure quality, timely delivery, and implementation of CST services
• Develop and maintain study-specific CST plans and contribute to functional project plans
• Provide status updates, identify delivery risks, and serve as a central point of contact for CST-related issues
• Create and maintain CST metric reports for client delivery
• Attend internal and Sponsor meetings as a lead CST representative
• Maintain project documentation and ensure complete and accurate filing in the Trial Master File
• Identify risks and develop mitigation plans
• Participate in Sponsor, internal, or agency audits and inspections
• Manage CST scope, out-of-scope activities, overburn, revenue recognition when delegated, invoice management, and KOL contracts and management
• Plan, manage, and request CST resources and provide resource updates
• Train and mentor internal team members

• 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
• Excellent written and spoken communication, presentation, and interpersonal skills
• Good organizational, planning, customer service, and time management skills
• Ability to multitask under tight deadlines with 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
• Ability to travel as necessary, up to 25%

• Career development and progression
• Supportive and engaged line management
• Technical and therapeutic area training
• Peer recognition
• Total rewards program
• Inclusive culture
• Reasonable accommodations, when appropriate, under the Americans with Disabilities Act