锦鲤求职岗位描述
1）Become the internal expert in the disease area and support the primary contact person to external stakeholders, including KOLs, investigators, regulatory agents, patient society and media.
2) Support the project team for the dossier preparation for regulatory submission and approval.
3) One of the responsible person for delivering clinical development plan of the IP during clinical development. Provide medical/scientific input on ongoing, or planning sponsored or supported clinical trial.
4) Ownership of study documents (Protocol, ICF, CRF and CSR et al.) to ensure drug safety, regulatory and ethical compliance. Develop and execute medical monitoring plan for assigned projects, such as review of medical coding, protocol deviations, QA log, safety data et al.
5) Interact with investigators during conduct of trial to be aware of any recruitment, other operational issues, and/or medical challenges, and to offer solutions and suggestions on medical aspects.
6) Involve in the project team meetings, and provide with resolution of medical and safety related queries from sites and project team.
7) Provide the medical training to the relative study team members.
8) Handle other tasks as required by Supervisor.
Requirements:
1) Master or above in Clinical Medicine. At least 2 years clinical development experience in a pharmaceutical company. Experience in urologic oncology projects is preferred.
2) Familiar with the whole process of drug research and development, proficient in the whole process of clinical trials.
3) Strong self-learning consciousness, good communication skills & teamwork spirit.
4) Excellent written and verbal communication skills in English.
5) Clinical practice experience in the hospital is preferred.