Senior Clinical Project Manager

Tasks and responsibilities:

• Leads, motivates, sets objectives, and manages performance of the assigned resources to assure completion of organizational goals, in a diverse and inclusive environment
• Oversee the clinical projects of assigned resources including trial management, timelines, budgets, and vendors, including the review and preparation of specific budget amendment.
• Identify training needs to foster high level of performance, support career development.
• Collaborate in the preparation of new quotations for clients and interaction during the negotiation phase.
• Ensure the execution of the clinical trials entrusted to the Sponsor in compliance with the deadlines, guaranteeing the achievement of the qualitative/quantitative objectives agreed with the Sponsor.
• Coordinate and drive all the clinical services involved in the project (Medical Writing, Start-up, Data Management, Biostatistics, Feasibility, Monitoring) during the entire life cycle of the study and as per applicable SOPs, budget and timelines agreed internally and with Sponsor and applicable regulations.
• Act as the main line of communication to relevant stakeholders and provides input to feasibility, study design, budget development and ensures progress reporting (resources, budget and timelines).
• Lead the periodical Sponsor meeting/Call. Finalize and approve the related minutes.
• Acquire the study documentation produced by the Sponsors and collaborate and coordinate the study core documents preparation required for the submission and application for approval of the study.
• Preparation and maintenance of Study Manuals.
• Set-up and maintenance of the Trial Master File.
• Set-up and maintenance of the Investigator Study File and coordination of delivery to experimental centers involved in the study.
• Lead the monitoring activities as per monitoring plan, budget and agreement with Sponsor.
• Keep aligned, with expected metric, the timelines related to the Monitoring visit report delivery.
• Provide specific study training (Protocol, CRF, etc.) for the 1MED Study team and, where required, for the hospital staff involved.
• Participation in Investigator Meetings and/or teleconferences related to the assigned study and drafting of the minute.
• Manage the findings found during an audit/inspection of a clinical trial and ensure that the necessary corrective actions are implemented.
• Ensure that serious adverse events are managed in accordance with the protocol and applicable legislation.
• Implement and maintain the necessary procedures for the management of clinical trials in accordance with GCP/ISO/MDD/MDR and all applicable regulation.
• Report major violations of protocol, GCP and SOPs to the Head of Quality Assurance and Top Management.
• Escalate to the direct superior all deviation from the qualitative/quantitative objectives, deadlines and budgets.