The Clinical Project Manager provides input to the overall operational trial(s) implementation, manages trial(s) timelines, budget, feasibility, country identification and sites selection, enhanced patient recruitment, and functions as the primary liaison for internal stakeholders and vendors.
Accountable to deliver Trial(s) on time, within budget, and with highest achievable quality.
Assist in the review, development and/or writing of clinical trial documents and manuals, including but not limited to Protocol, Case Report Forms, informed consent forms, Clinical Study Report and other regulatory documents.
Select, coordinate and monitor activities of vendors Review of monitoring reports and conduct co- monitoring visits, as needed.
Participate in data review and discrepancy resolution.
Ensure set up and maintain all systems in order to plan and implement trial(s) and track progress.
Generate reports to update management on conduct of trial.
Ensure appropriate clinical trial supply plans are implemented and managed.
Develop recruitment plans, risk-mitigation plan, monitor,
and implement contingencies as required.
Participate in monitoring study safety.
Review key study quality metrics (e.g., eligibility, primary endpoint data, etc.) Perform initial review of CRO and other third party study vendor invoices to ensure that work is performed in accordance with scope of work.
Assist with CRA and third party vendor training on protocols and practices.
Assume responsibility to participate as a member of working groups and perform special projects, as assigned.
Minimum of 4 years of experience in the biopharmaceutical industry or other relevant clinical research experience in the conduct and management of multinational clinical trials.
Must have working knowledge of ICH Good Clinical Practices and other relevant regulatory/health authority experience.
Experience in executing a wide range of clinical trial activities (from initiation to clinical study report).
Used to work in
📌 Clinical, Project Manager (Italia)
🏢 Iqvia
📍 Italia