The Clinical Project Manager is responsible for the management of clinical projects and studies by collaborating with Clinical Affairs in the implementation of various team and company objectives for the execution of clinical studies. The role, in close collaboration with the Project Leader, is accountable for achieving successful deliverables, working together with the clinical team while meeting company and regulatory requirements according to time, quality, scope and within budget. The position is office-based.
Responsibilities
Proactively manage project-level operations, including but not limited to management of trial timeline, budget, resources with consideration of quality standards and risk mitigation
Provide project leadership and project support for both U.S. and International Clinical Trials consistent with applicable laws, regulations, guidelines and policies.
Ensure conformance with GCP,



trial protocols and trial safety reporting requirements
Lead projects that support division and company objectives
Adhere to study execution strategy in order to meet business objectives
Implement immediate and long-range plans to carry out objectives for new and ongoing clinical trial research in support of regulatory submissions in a timely and efficient manner
Ensures protocol adherence at all clinical centers in order to maintain a high level of compliance, data integrity and the highest possible percentage of patient follow-up
Support IRB/EC/CA submissions and renewals
Contribute to the strategic development of FDA submissions (510K), Premarket Approval, IDE, De Novo and Medical Device Reporting
Oversee site contracts,

📌 Clinical Project Manager (Roma)
🏢 Meditrial Europe
📍 Roma