Lead oversea and China clinical trials (phase 1-3) management and delivery as aligned timeline
Ensures that clinical trial projects are properly resourced, managed and executed within budget and in accordance with established timelines and quality standards；
Lead manager of protocols; prepares protocol, amendments, CRF, informed consent form, operations and other documentation required for conduct of a clinical trial；
Maintains and manages internal clinical trial files and documents ；
Prepare required regulatory documents, such as annual reports, updating of the IB, and final study reports for assigned protocols；
Serve as clinical monitor ；
Manages the day-to-day clinical operations, including management of vendors (e.g., CRO) and coordination of activities
Participates in investigator meetings and follow up；
Coordinates and plans for the availability of clinical and non-clinical supplies necessary to meet study requirements；
Travel to sites when necessary ；
Maintains proper communications with other departments to ensure communication and good relationships in connection with matters related to clinical trial projects
Other duties as assigned.
Bachelor or Master Degree，preferably in related scientific subjects (clinical, medical study, pharmacology, biology, etc.).
The SD/Director, Clinical Operations should have a minimum of 5 years experience in the pharmaceutical industry including oversea Oncology products clinical trials experience like US Australia or Asia Pacific region, with minimum 5 years direct experience in planning and managing clinical trials.
The candidate must have solid understanding of pharmaceutical clinical development process and have experience with clinical monitoring.
The candidate should have significant experience with responsible roles in the conduct or management of Phase I and II clinical trials.
Ability to travel.
If you are interested in this position, please send your resume to us!
Beijing：renshanghe@sumgenbio.com +86-10-56315401-808 Ms. Ren
Hangzhou/Shanghai：hr@sumgenbio.com +86-571-86837379 Ms. Zhao
Copyright Rm. 301, F3, Building C, Block 2, No. 688, Bin'an Road, Changhe Zhejiang ICP Filing No. 18039044
