We are seeking an experienced Project Manager / Senior Clinical Research Manager (PM/SCRM) to provide oversight and quality assurance support for an ongoing hospital-based study in the US. This senior role requires a strong background in clinical operations, with responsibilities focused on reviewing site and CRO performance, identifying risks, and preparing corrective action plans to ensure study delivery.

REQUIREMENTS

• Strong background as a CRA/CTM, with extensive clinical trial monitoring and management experience.
• Experience in hospital-based studies; prior exposure to oncology and infectious diseases is highly desirable.
• Demonstrated expertise in quality assurance and oversight of clinical operations.
• Excellent communication and organizational skills, with ability to work independently across multiple stakeholders.

• Oversee performance of approx. 20 hospital-based sites across the US.
• Provide quality oversight of CRO activities, ensuring compliance with protocol, ICH/GCP, and regulatory requirements.
• Conduct a combination of onsite visits and remote reviews to evaluate study progress.
• Identify operational issues and develop corrective and preventive action plans (CAPA).
• Serve as a liaison between sponsor, CRO, and site teams.
• Contribute to study governance and oversight reporting.