Key Responsibilities:

1. Clinical Trial Design & Planning:

Lead the design of animal trial protocols for FLASH radiotherapy technology, including dose grouping, observation indicators, animal model selection, and ethics approval process.
Develop early clinical trial protocols, keeping up to date with both domestic and international developments in FLASH radiotherapy and related fields to ensure scientific and cutting-edge protocols.
Coordinate the initiation and execution of multi-center clinical trials and establish a trial quality management system.

2. Patient Recruitment & Trial Site Management:

Design and implement effective patient recruitment strategies and establish communication mechanisms with partner hospitals to ensure recruitment targets are met.
Oversee day-to-day trial site management, including patient screening, informed consent, follow-up during treatment, adverse event collection, and data recording.
Resolve issues arising during the trial and manage cross-departmental resources (e.g., medical, statistics, quality control, regulations) to ensure trials are conducted on time and with high quality.

3. Data Analysis & Report Writing:

Monitor, verify, and conduct preliminary analysis of clinical trial data to ensure accuracy, integrity, and consistency.
Assist or independently write research reports, data analysis summaries, and other related academic materials based on trial progress and requirements.

4. Academic Support & Training Delivery:

Study clinical literature, industry trends, and competitor information related to FLASH radiotherapy, providing valuable analysis reports and technical white papers.
Conduct training for medical professionals at partner hospitals (doctors, physicists, research nurses) on equipment usage, trial protocols, and treatment planning.
Actively participate in relevant academic conferences and seminars, gathering feedback from KOLs (Key Opinion Leaders) to provide input for product development and trial design.

5. Registration & Compliance Management:

Assist the company in completing NMPA (National Medical Products Administration) registration for Class III medical devices, preparing and organizing clinical evaluation materials.
Strictly adhere to and maintain the company's Clinical Trial Quality Management System (GCP) and relevant regulatory requirements to ensure all trial activities are compliant.

Qualifications:

1. Educational Background:

Bachelor's degree or higher in Clinical Medicine, Biomedical Engineering, Pharmacy, Public Health, Epidemiology, or related life sciences; Ph.D. preferred.
Hold a GCP certification issued by the National Medical Products Administration or have received CFDA (now NMPA) clinical trial regulations and GCP training.

2. Experience:

At least 3 years of practical experience in the operation and management of medical device clinical trials, with preference given to those with radiotherapy clinical trial experience.
Experience in leading or core participation in at least one successful Class III medical device clinical trial (especially innovative devices).
Familiarity with clinical pathways, treatment guidelines, and relevant technical standards in the radiotherapy field.

3. Core Competencies:

Proficient in clinical trial design methods (e.g., randomized controlled trials, single-arm trials, adaptive design) and statistical principles, with the ability to independently analyze clinical trial data (including survival analysis, toxicity assessment, etc.).
Proficient in using clinical trial data management systems.
Excellent communication, coordination, organization, and project management skills, capable of effectively managing multiple stakeholders.

4. Language & Other Requirements:

Excellent written and verbal communication skills in Chinese, capable of writing professional reports and training materials.
Good reading comprehension of English, with the ability to independently retrieve, understand, and analyze English literature. Experience in writing or contributing to SCI papers is a plus.

Contact number: 0816-2130000 Please send your resume to the mailbox: HRZJ@changhong.com. The subject of the email should be: (Name + Job Position Applied for)