工作职责:
1. To support line manager to prepare medical document package including protocol synopsis, briefing book, investigator’s brochure, protocol, ICF, study report, safety summary, efficacy summary etc., for regulatory submission and ethical committee submission together with internal and external partners.
2. To perform frequent clinical data review activities in clinical trials to ensure compliance of documentation to GCP, SOPs, study protocol, and relevant guidelines in pharmacovigilance as well as to ensure data integrity and patient safety protection.
3. Communicate with medical experts according to the requirement of clinical trials.
4. To support data publications per internal/external needs.
5. To proactively monitor the literature for new scientific information; identify publications that would be of scientific and business interest, analyze and communicate relevance of information internally in an accurate, balanced and timely manner.
6. Proactively seek developments in given scientific field and provide current awareness to internal stakeholders.
7. Maintain and update medical information database of Carsgen’s product and competitor intelligence.
8. To provide medical support and training on demand.
9. Work with line manager to ensure communication materials and activities are conducted with due regard to all applicable local, regional, global and national legal requirements, regulation, guidelines, codes of conduct, company policies and accepted standards of best practice.
10. Other tasks assigned by line manager.
任职资格:
1. Master’s degree or above in clinical medicine. Major in oncology is a plus.
2. 1+ years of working experience in clinical related positions. First-hand experience in clinical research/drug safety/or relevant is preferred.
3. Capability of English reading and writing. Fluent spoken English is a plus.
4. Display the highest level of integrity that is aligned with CARsgen value.