Clinical Project Manager

Clinical Project Manager

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The Clinical Project Manager provides leadership and end-to-end management of clinical trials, ensuring alignment with Sponsor expectations and organizational objectives. This role combines strategic oversight with hands-on project execution, fostering cross-functional collaboration and delivering studies on time, within budget, and in compliance with applicable regulations and quality standards.

Key Responsibilities Lead, motivate, and manage assigned team members by setting clear objectives and monitoring performance to ensure the achievement of organizational goals in a diverse and inclusive environment. Oversee the full lifecycle of clinical projects, including planning, timelines, budget management, and vendor coordination, as well as the review and preparation of budget amendments. Identify training needs to enhance team performance and support career development. Contribute to the preparation of client proposals and support negotiations during the contracting phase. Ensure the execution of clinical trials in compliance with agreed timelines and quality/quantity standards set with the Sponsor. Coordinate all clinical services involved in the project (Medical Writing, Start-up, Data Management, Biostatistics, Feasibility, Monitoring) throughout the study lifecycle, ensuring adherence to SOPs, budget, timelines, and applicable regulations. Act as the primary point of contact for stakeholders, providing input on feasibility, study design, budget development, and progress reporting (resources, budget, and timelines). Lead periodic Sponsor meetings/calls and finalize and approve related minutes. Manage Sponsor-provided study documentation and coordinate the preparation of core documents required for regulatory submissions and study approval. Prepare and maintain Study Manuals, Trial Master File (TMF), and Investigator Study File (ISF), ensuring proper distribution to participating sites. Oversee monitoring activities in line with the monitoring plan, budget, and Sponsor agreements, ensuring timely delivery of monitoring visit reports. Deliver study-specific training (Protocol, CRF, etc.) to the internal study team and, where required, to site staff. Participate in Investigator Meetings and teleconferences, including preparation of meeting minutes. Manage audit and inspection findings, ensuring appropriate corrective and preventive actions (CAPA) are implemented. Ensure proper handling of Serious Adverse Events (SAEs) in accordance with protocol and applicable regulations. Implement and maintain procedures for clinical trial management in compliance with GCP, ISO, MDD/MDR, and all applicable regulations. Report major protocol, GCP, and SOP violations to Quality Assurance and Top Management. Escalate any deviations related to quality, timelines, and budget to the direct supervisor.

Requirements Bachelor’s or Master’s degree in a scientific discipline, or equivalent experience (at least 10 years) in clinical trial-related activities. At least 5 years of experience in the role of Clinical Project Manager.

Key Skills Excellent organizational and project management skills. Strong client-facing and internal communication skills, including negotiation abilities. Results-oriented mindset with strong problem-solving skills. Solid knowledge of clinical trial design and development. xpavfwm Good command of English (written and spoken) and French.