Clinical Project Manager
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Può ottenere maggiori dettagli sulla natura di questa posizione e sui requisiti per i candidati leggendo quanto segue.
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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.
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Key Responsibilities
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- 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 \n
- 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 \n
- 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. xdwybme
- Good command of English (written and spoken) and French.