| Position |
Education |
Number |
Salary |
| Clinical Research Associate (CRA) |
Bachelor's degree or above |
several |
Negotiable |
Professional:
1. Bachelor's degree or above in medicine, pharmacy, biology, nursing, or a related field. Outstanding fresh graduates are also acceptable. 2. Familiarity with ICH/GCP and China GCP regulatory requirements. 3. Proficiency in Microsoft Office and other common office software. 4. Teamwork spirit, good communication, organizational, and coordination skills. 5. Hardworking, responsible, and able to work under pressure. Work Location: Suzhou Industrial Park Submission Email: ying.zhang@teligene.com ; ruolan.kong@teligene.com
Job description:
1. Responsible for the selection of principal investigators at research sites and the establishment of study budgets. 2. Responsible for selection of clinical trial institutions, preparation of ethics submission documents, signing of clinical trial agreements, and organization of investigator meetings. 3. Follow up on clinical trial progress, assist investigators in resolving issues that may arise during subject screening, enrollment, and follow‑up. 4. Monitor quality at clinical research sites, identify issues, and propose solutions. 5. Track clinical study progress, coordinate site staff and resources, and complete the study according to the project timeline. 6. Submit monitoring reports in a timely manner. 7. Keep the investigator file (ISF/TMF) up to date. 8. Verify the receipt, dispensing, and return of investigational product, and maintain relevant records. 9. Ensure that study data are recorded in the case report forms (CRFs) in a timely, accurate, and complete manner. 10. Close out study sites and assist with inspection preparations at research institutions.
|
| Clinical Medical Specialist |
Bachelor's degree or above |
several |
Negotiable |
Professional:
1. Bachelor's degree or above; clinical medicine major and master's degree preferred. Experience in pharmaceutical company projects preferred. Proficient in Microsoft Office software. Good communication and presentation skills. Work Location: Suzhou Industrial Park Submission Email: ying.zhang@teligene.com ; ruolan.kong@teligene.com
Job description:
· Responsible for daily medical affairs and clinical support work.
|
| Clinical Audit (QA) |
Bachelor's degree or above |
several |
Negotiable |
Professional:
1. Bachelor's degree or above in medicine, pharmacy, life sciences, or related fields. 2. At least 1 year of CRA experience or at least 1 year of clinical research audit experience. 3. Familiar with clinical trial regulations and policies (e.g., regulatory requirements, GCP, relevant guidelines). 4. Good communication and presentation skills, including coordination and communication with internal and external stakeholders and partners. Work Location: Suzhou Industrial Park Submission Email: ying.zhang@teligene.com ; ruolan.kong@teligene.com
Job description:
1. Responsible for planning and conducting audits, completing audit reports, and following up on the implementation of corrective and preventive actions. 2. Responsible for reviewing and assessing the quality system, as well as the implementation and effectiveness verification of related corrective and preventive actions. 3. Participate in planning, developing, and implementing clinical SOPs to ensure compliance with GCP, regulatory requirements, and international standards. 4. Coordinate training for clinical staff, maintain employee training records, and provide training on clinical trial quality and compliance.
|
| Clinical Medical Manager |
Clinical Medical Manager |
1 |
Negotiable |
Professional:
1. Master's degree or higher in clinical medicine (oncology-related). 2. Prior clinical work experience, with solid medical knowledge and clinical practice experience in solid tumors preferred. Work Location: Suzhou Industrial Park Submission Email: ying.zhang@teligene.com ; ruolan.kong@teligene.com
Job description:
1. Responsible for or participate in the drafting and revision of clinical protocols for the company's new drug projects, as well as the preparation of related clinical documents, and assist in resolving medical issues throughout the project. 2. Provide medical support during clinical trials, answering medical questions raised by investigators, subjects, clinical operations, and other departments within the company. 3. Collect and organize literatures and materials for writing clinical study reports, and assist in the drafting and review of clinical reports. 4. Communicate and liaise with CDE reviewers, clinical experts, CROs, CRCs, and other clinical research resources to ensure the smooth progress of clinical studies. 5. Complete other temporary tasks assigned by leadership.
|
| Clinical Project Manager |
Clinical Project Manager |
1 |
Negotiable |
Professional:
1. Bachelor’s degree or above in clinical medicine, pharmacology, biology, or related fields. 2. At least 5 years of clinical research experience, including 3 years of project management experience in anti-tumor new drug clinical research. 3. Mastery of GCP and SFDA regulations related to new drug clinical trials; familiarity with trends in domestic drug clinical development. 4. Excellent project management, expert communication, and coordination skills. Work Location: Suzhou Industrial Park Submission Email: david.zhang@teligene.com ; ying.zhang@teligene.com ; ruolan.kong@teligene.com
Job description:
1. Responsible for the implementation of the company’s new drug clinical trials, monitoring the clinical trial process to ensure compliance with GCP requirements. 2. Communicate and coordinate with clinical researchers, CROs, and other partners to advance clinical project timelines. 3. Participate in the development of clinical study plans and protocols, and evaluate and select cooperative sites. 4. Participate in drafting clinical-related documents for project submission, and Assist registrants with new drug application procedures. 5. Support communication and provide input on clinical information for drug evaluation and review.
|
| Clinical Medical Director |
Master's degree or above |
1 |
Negotiable |
Professional:
1. Master’s degree or above in clinical medicine, pharmacy, biology, or related fields; background of clinical medicine preferred. 2. Familiar with regulations governing clinical research and the entire GCP clinical trial process, with at least 10 years of clinical research management experience. Work Location: Suzhou Industrial Park Submission Email: david.zhang@teligene.com ; ying.zhang@teligene.com ; ruolan.kong@teligene.com
Job description:
1. Oversee the entire process of clinical drug trials, including protocol development, selection of clinical trial sites, effective project implementation, and quality control. 2. Communicate and liaise with CDE review experts, clinical experts, CROs, CRCs, and other clinical research resources to ensure smooth conduct of clinical studies. 3. Responsible for departmental process and system establishment, as well as staff training and performance evaluation.
|
| Clinical Operations Director |
Master's degree or above |
1 |
negotiable |
Professional:
1. Master’s degree or above in clinical medicine, pharmacy, or related fields. 2. At least 8 years of clinical research management experience in the pharmaceutical industry. 3. Proficient in GCP regulations, familiar with clinical trial requirements and relevant policies/regulations. 4. Strong sense of responsibility, innovation, teamwork, and adaptability. Work Location: Suzhou Industrial Park Submission Email: david.zhang@teligene.com ; ying.zhang@teligene.com ; ruolan.kong@teligene.com
Job description:
1. Develop clinical research strategies and efficiently manage the clinical team, external collaborations, and CROs. 2. Develop clinical study protocols, communicate with corresponding clinical trial centers, and provide training. 3. Supervise the execution of clinical protocols. 4. Evaluate, select, and establish collaborations with clinical trial sites and centers, and sign cooperation agreements. 5. Collaborate with clinical trial centers to accelerate patient recruitment. 6. Track amendments and interpretations of policies and regulations related to new drug clinical trials. 7. Ensure compliance of clinical research with regulatory and policy requirements. 8. Control clinical trial budget and timeline. 9. Submit clinical trial progress reports to Senior management. 10. Provide solutions and responses to issues arising during clinical trials. 11. Assist in establishing and strictly adhering to the company’s clinical SOPs. 12. Support the evaluation and recommendations for clinical application of new drugs introduced and developed. 13. Assist the Regulatory Affairs department in submitting NDA s and obtaining new drug approval.
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