Responsibilities:
1. Conduct monitoring visits at assigned clinical trial sites in accordance with GCP and the company’s SOPs, ensuring that trial data are authentic, accurate, complete, and compliant with regulatory requirements.1. Responsible for the overall project management of Phase II/III clinical trials for innovative ophthalmology drugs targeting retinal diseases, such as nAMD and DME.
2. Develop and execute project plans, including timelines, milestones, budgets, and resource allocation.
3. Coordinate cross-functional collaboration among Medical, Biostatistics, Data Management, Pharmacovigilance, Regulatory Affairs, and other relevant functions.
4. Liaise with CROs, SMOs, and third-party vendors, including imaging reading centers, central laboratories, and other service providers.
5.Develop and drive patient recruitment strategies, with a focus on accelerating enrollment at key investigational sites.
6. Ensure clinical trial execution complies with China GCP and ICH-GCP requirements.
7. Identify and manage project risks related to enrollment, study endpoints, data quality, and other critical project aspects.
8. Manage vendor performance and participate in contract and budget control.
9. Organize project meetings and report project progress to senior management.
Qualifications:
1. Bachelor’s degree or above in Medicine, Pharmacy, Biology, or a related discipline.
2. More than 5 years of clinical research experience, with Phase III project management experience.
3.Experience as a Project Manager at a sponsor company or as a Senior Project Manager at a CRO.
4. Familiarity with China GCP and ICH-GCP.
5. Strong project management skills and cross-functional communication capabilities.
6. Experience in ophthalmology projects, especially retinal diseases, is preferred.
7. Experience in multicenter clinical trial management is preferred.
8. Experience in regulatory submissions or communication with the CDE is preferred.