- Support medical director in drafting clinical trial protocol and study report.
- Contribute to the medical/scientific input given for the development of trial-related documents such as IB, ICF etc. and processes which reside in other line functions.
- Establish and maintain liaisons with investigators.
- Serve as back-up medical monitor to provide medical support to trial sites and clinical operation team. Support regulatory filing where medical expertise is required.
- Support drug discovery when clinical experience is needed for the medical “translation”.
- Lead clinical trial data review and generate clinical queries, quality control and data validation for clinical study reports, publications and internal/external presentations.
- Prepare and conduct regular meetings with investigators. Support clinical study site and CRO selection in trial conduct and clinical trial outsourcing process.
- Support the regional clinical strategy for a project through Clinical development, in partnership with relevant matrix team members.
- Compliance with GCP, SOP and regulatory requirements
- Study planning, preparation, conduct and report in terms of timeline, quality and quantity (recruitment target).
- Other tasks as assigned.
- Education: Graduate from Clinical Medicine with bachelor degree or above.
- Experience: At least 2-5 year clinical practice / clinical development / clinical research experience. Therapeutic area experience esp. oncology or immunology. Working experience with international pharmaceutical company or CRO is preferable. GCP experience is preferred.
- Skills: Proficiency in English and good computer skill at office software. Excellent planning, organization and problem solving abilities. Good communication and interpersonal skills.
- Competency: Good project management skill. Team work and leadership. Self- motivation and good risk management.