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Headquarters: Building F2, 88 Kechuang, 6th St., Beijing , China
Beijing Office : Suite 2105, Building T2, Dazu Square, Beijing , China
Shanghai Office: 595 North Caoxi Road Building A Suite 6009 , Shanghai China
Boston Office: 99 Hayden Ave, Lexington, MA 02421, US
Tel: +86 010-56315466
Fax: +86 010-56315314
1 Provides medical support for clinical development, covering the stages from pre-IND to post-marketing.
2 Monitor medical and safety data of subjects in clinical trials to ensure trial treatment and subject safety.
3 Review subject’s inclusion screening information to ensure that subjects meet protocol requirements prior to joining the clinical study.
4 Draft CDP (clinical development plan) and coordinate internal staff and resources to accomplish this work.
5 Draft and review documents related to pre-IND and IND, including clinical trial protocol, investigator manual and informed consent.
6 During the clinical trial, revise the protocol and informed consent as required.
7 Draft posters and abstracts of published clinical trial results
8 To training new colleagues.
9 Support clinical trial related meetings, such as investigator meeting, dose escalation meeting, etc.
10 Provide Clinical trial protocol training and industry-leading research findings to Internal team.
1 M.S./Ph. D in a healthcare field with at least 3 years’ experience in clinical research.
2 Sub-specialty training or board certification in oncology, hematology is preferred.
3 Experience in Phase I protocol development and clinical strategy development is preferred.
4 Industry experience is preferred, although academic candidates with significant relevant experience in clinical trials and strategic development will also be considered.
5 Knowledge of the regulatory environment and experience with working with regulatory authorities is preferred.
6 Ability to integrate biological knowledge into clinical development strategy.
7 A creative problem solver with the proven ability to work independently and collaboratively in a fast-paced, results-oriented, and dynamic environment.
8 Interpersonal skills and a demonstrated ability to work well within team structure is essential.
9 Strong written and verbal communication skills.