Alliance for Clinical Trials in Oncology

Project Manager

• Acts as operations lead on one or more AFT studies
• Serves as primary point of contact between AFT and pharmaceutical industry partners associated with assigned AFT studies
• Assists with the design, planning, implementation, conduct, and management of clinical studies from initiation through completion
• Represents AFT Clinical Operations on the cross‐functional project team, and liaises with medical, statistical, regulatory, quality, and financial personnel
• Manages one or more AFT junior operations staff
• Oversees participating study vendors, including vendor agreements, statements of work, and vendor budgets
• Manages overall study budget, including approvals of all subject visit payments and vendor invoices for assigned studies
• Oversees and manages the development of study‐related documents together with the scientific team and protocol development team including, but not limited to, study protocol, informed consent forms, laboratory manuals, eTMF plans, etc.
• Assists in the design, configuration, development, and oversight of study-level systems such as EDC, eTMF, and CTMS
• Organizes, schedules, and leads study teleconferences and in-person meetings with investigative sites, physicians, vendors, and consultants as needed
• Serves as the central escalation point for all study issues originating with component groups such as data management, site management, site monitoring, laboratory management, etc., and tracks escalated issues through to resolution
• Reviews study-related materials including, but not limited to, monitoring reports, key performance metric reports, clinical trial agreements, etc. as needed
• Works with the AFT Regulatory Manager to support regulatory filings as needed
• Initiates and maintains study protocol(s) and associated amendment tracking
• Oversees site activities on assigned studies, including feasibility, activation, accrual, maintenance, and closure
• Tracks study progress and manages clinical timelines, including regulatory document collection, IRB approval, enrollment, management of clinical supplies, etc.
• Helps build and maintain relationships with site investigators and other site study staff
• Assists with the reporting of clinical data for regulatory or medical scientific purposes, including study publications
• Participates in the development and implementation of SOPs and Clinical Operations processes and systems
• Handles other duties as assigned.