
Clinical Trials Project Manager
5 days ago
We are representing a confidential, fast-growing company at the forefront of **dental AI innovation**. The company is developing a **revolutionary AI-powered screening device/software**aimed at transforming early detection and diagnosis in oral healthcare.
To support product validation and global market entry, we are seeking a **Clinical Trials Project Manager**to lead and manage clinical studies from initiation to close-out.
**Key Responsibilities**:
- Lead and manage end-to-end clinical trial activities (planning, execution, monitoring, and reporting) in alignment with GCP, regulatory requirements, and project timelines
- Collaborate with cross-functional teams including R&D, regulatory affairs, QA, and data science to ensure study objectives are met
- Oversee the selection, initiation, and coordination of clinical trial sites, investigators, and vendors
- Prepare and maintain all clinical trial documentation (protocols, informed consent forms, CRFs, study reports)
- Monitor trial progress, manage budgets and timelines, and mitigate risks proactively
- Ensure compliance with all applicable ethical and regulatory standards including IRB/IEC submissions
- Coordinate data collection and validation in conjunction with the AI/tech team for real-world performance benchmarking
- Report trial milestones and results to internal leadership and external regulatory bodies
**Requirements**:
- Bachelor’s degree or higher in Life Sciences, Biomedical Engineering, Dentistry, Public Health, or a related field
- 3-5 years’ experience managing clinical trials, preferably in **medical/dental devices**or **digital health/AI**:
- Strong understanding of GCP and relevant regulatory frameworks
- Experience with investigator-initiated trials, device/software validations, or real-world data studies is a plus
- Excellent project management and stakeholder coordination skills
- Strong written and verbal communication, especially in technical and regulatory documentation
- Familiarity with dental or radiology clinical environments is advantageous
- Ability to manage multiple priorities in a **fast-paced, startup-like environment
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