Job Purpose:
Lead and manage global clinical trial projects with primary focus on North American regions, ensuring successful delivery within contractual scope, timeline, budget, and quality requirements. Serve as the key liaison between North American stakeholders and global project teams, promoting operational excellence and maintaining strong client relationships while adhering to ICH-GCP, local regulations, and Tigermed SOPs.
Key Responsibilities:
- Plan and execute global clinical trials with emphasis on North American operations, including site selection, initiation, monitoring, and close-out activities.
- Serve as the primary contact for North American sponsors, investigators, and regulatory stakeholders, ensuring alignment with global project objectives.
- Develop and implement comprehensive project management plans (including monitoring plans, risk management plans, and communication plans) tailored for North American operations.
- Manage cross-functional project teams and third-party vendors, providing guidance and support for North American project activities.
- Monitor project progress, quality, and compliance at North American sites, implementing corrective actions as needed.
- Conduct financial management and cost control for North American project components in accordance with contract requirements.
- Maintain professional communication in both English and Chinese as working languages for all project-related correspondence and collaboration.
Qualifications:
- Bachelor's degree or above in Medicine, Pharmacy, Biology, or a related field.
- Minimum of 4 years of clinical trial project management experience, with at least 2 years focused on North American operations.
- Full professional proficiency in both English and Chinese (written and spoken) as working languages.
- Comprehensive knowledge of ICH-GCP, FDA regulations, and the North American clinical trial landscape.
- Experience in a CRO or sponsor environment with exposure to global clinical projects is preferred.
- Willingness to relocate to North America is highly preferred; long-term remote work arrangements will also be considered.
- Strong leadership, communication, and cross-cultural collaboration skills.
- Proficiency in Microsoft Office applications and clinical trial management systems.
