Clinical Project Manager II
Core
Execute, oversee, and deliver clinical studies for pharmaceutical, biotechnology, medical device, and consumer health clients, managing vendors, sites, and CRO activities with a focus on oncology and hematology.
Role type
Clinical Project Manager II
Builds
Clinical studies and trials
Domain
Healthcare / Clinical Research / Contract Research Organization (CRO)
Deliverable
client delivery
Required skills
Clinical trial operations, GCP/ICH guidelines, complex oncology and hematology trial management, vendor and site management, budget and resource management, change order identification, quality management system (QMS) compliance, invoice and timesheet review, administrative close-out procedures
Preferred skills
Feasibility Associate (FEA) experience, co-monitoring visit experience, Microsoft Project and CTMS proficiency
Technologies
Microsoft Project, CTMS, EDC software, SharePoint, Word, Excel, PowerPoint
Responsibilities
Organize Monitor's and Investigator's Meetings; perform co-monitoring visits; monitor sites for assigned projects; review and approve third-party invoices and contractor timesheets; develop alternative solutions for study timelines, resources, and budgets; identify and communicate issues and implement corrective action plans; assess scope of work against contractual agreements; manage resource deviations and project profitability; submit invoice requests and payment authorizations; track expenditures against trial budgets; organize quality checks of study documentation; ensure administrative close-out procedures are completed; comply with Company's QMS, ISMS, and PIMS requirements
Seniority
Mid-level, hands-on IC
