工作地点：

国外-印度尼西亚

工作职责：

This position will be based in Indonesia.

Main responsibilities
Perform specific tasks related to clinical trial project management, including drafting clinical trial protocols, coordinating on-site management, cooperating with CROs, and reviewing trial reports, etc., to ensure the smooth progress of international clinical projects.

Main Responsibilities
1. (Protocol Execution) Participate in the development and drafting of clinical trial protocols. Execute trial designs by managing subject recruitment, data collection, and analysis coordination, ensuring a scientific and feasible research.
2. (Project Management) Conduct daily management of clinical trial projects, including tracking project progress, recording and reporting issues, and coordinating and managing necessary resources to ensure smooth project execution.
3. (Site Management) Manage and coordinate clinical sites, including but not limited to subject recruitment, data monitoring, and trial logistics. Communicate fluently in English to ensure smooth site operations and workflow.
4. (Document Drafting) Draft or review relevant clinical trial documents and forms to ensure compliance with ICH-GCP guidelines and clinical trial requirements.
5. (Data Collection and Analysis) Accurately collect and organize data from clinical trials. Coordinate with collaborators for basic clinical data summaries and preliminary analyses.
6. (Monitoring and Quality Control) Conduct on-site monitoring and quality control for clinical trials, with readiness for both domestic and international travel.
7. (Frontier Knowledge Tracking) Actively learn about innovative and cutting-edge technologies and methodologies in clinical trials. Assist project leader in enhancing the efficiency and quality of clinical trials.
8. (Standard Operating Procedures Development) Assist in drafting and optimizing SOPs related to international clinical project management to ensure compliance with relevant regulations and standards.
9. (Collaborative Coordination) Work with team members and other departments to collaboratively resolve challenges encountered during clinical project management.
10. (Relationship Management) Maintain partnerships with research institutions, clinical centers, and CRO companies to facilitate project progress and improve partner satisfaction.

任职资格：

Education
Applicants should have a bachelor’s degree or above in preventive medicine, public health, clinical medicine, statistics, life sciences, biopharmaceuticals, etc.

Work Experience
- At least two years of working experience in clinical research, drug development, clinical trial management and other related fields.
- Fresh graduates with rich practical experience can be considered.

Basic professional knowledge
- Understand the design principles, methodology and common statistical concepts of clinical trials.
- Proficient in knowledge in the fields of medicine and biology, including disease pathophysiology, pharmacology and drug metabolism.
- Understand the principles and processes of clinical trial data management, including data collection, verification, cleaning and analysis.
- Be familiar with clinical trial ethics and related procedures, and be able to ensure that trial activities comply with ethical standards and the requirements of the ethics committee.

General ability and quality
- Have good project overall management, operation and coordination skills, and have a good sense of responsibility.
- Excellent communication and teamwork skills, able to collaborate effectively with team members and other departments.
- Have a rigorous work attitude and pay attention to the compliance of process operations.
- Have the ability to learn and solve problems independently, and adapt to new technologies and new methods in a timely manner.
- Familiar with the general requirements of international clinical trial regulations, such as ICH-GCP and WHO general regulations.
- Have good English& Indonesian reading and writing skills, and be able to understand and write relevant scientific and technological literature and technical reports.
- Both English& Indonesian as native speaker or fluent communicate with international partners.