Clinical Project Manager

About the role

The Clinical Project Manager leads end‑to‑end management of clinical trials, ensuring alignment with sponsor expectations and organizational objectives. This role combines strategic oversight with hands‑on execution, driving cross‑functional collaboration to deliver studies on time, within budget, and in compliance with regulations.

Key responsibilities

• Lead and motivate assigned team members, set objectives, monitor performance and support career development.
• Oversee the full lifecycle of clinical projects, including planning, timelines, budget management and vendor coordination.
• Act as primary point of contact for sponsors, providing feasibility input, study design, budget development and progress reporting.
• Coordinate all clinical services (Medical Writing, Start‑up, Data Management, Biostatistics, Monitoring) throughout the study lifecycle.
• Manage sponsor‑provided documentation, maintain Trial Master File and Investigator Study File, and ensure regulatory submission readiness.
• Handle audit findings, implement CAPA, manage Serious Adverse Events and ensure compliance with GCP, ISO, MDR and other regulations.

Required profile

• Bachelor’s degree or higher in a life‑science discipline.
• Minimum 5 years of clinical research experience, including at least 2 years in project management or study leadership.
• Proven experience managing studies from start‑up through close‑out in pharmaceutical or medical‑device trials.
• Strong knowledge of ICH‑GCP, ISO 14155, EU MDR and related regulatory requirements.

Required skills

• Advanced use of EDC/eCRF platforms and oversight of study data collection.
• Knowledge of eTMF systems and CTMS for planning, tracking and reporting.
• Proficiency with Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
• Experience with project‑management and collaboration tools such as Microsoft Teams, SharePoint, Smartsheet or Monday.com.