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
Other tasks as assigned.
Graduate from Clinical Medicine with bachelor degree or above.
At least 3-5 year clinical practice / clinical development / clinical research experience. Therapeutic area experience esp. oncology or hematology. Working experience with international pharmaceutical company or CRO is preferable.
GCP experience is preferred.
Proficiency in English and good computer skill at office software.
Excellent planning, organization and problem solving abilities.