岗位职责:
1. Assist company’s clinical development planning and execution.
2. Assist to oversee company*s overall clinical development activitiesin medical monitoring and medical writing.
3. Play key role in providing medical and clinical inputs to theprojects, as well as insight into the process.
4. Provide medical review and clinical input on clinical protocoldesign, protocol adaptation, and monitoring on clinical trial execution.
5. Provide medical and scientific input of clients’ inquires and discussion.
6. Liaise with clients to support study design and site capabilities.
7. Oversee the clinical operation to ensure that the physical and mentalwell being of subjects is undiminished during the study.
8. Responsible for ensuring that the clinical trial is conducted perclinical development plan and
all applicable regulations.
9. Act as the primary clients* contact for medical and medical safetymonitoring. Contribute to medical writing on clinical study relateddocuments, including IB, study synopsis, protocol, CSR or other relevant documents.
10. Perform literature searches as needed for drafting document content.Interprets literature
information.
11. Attend study initiation meetings.
12. Liaise with clients regarding study design and site capabilities.
13. Assist clinical operations and client managers with sponsor visits.
14. Review pre-study physical examination and lab data to ensuresubjects recruited to meet
study inclusion exclusion criteria.
15. To help to develop and administer budgets, resource plans andperformance objectives for
the clinical development function.
16. To assist the training for junior medical writers and interns, as requested.
17. Closely monitor relevant therapeutic area movement, clinicalresearch updates and maintain sound medical / scientific capability.
任职要求:
1. Minimum M.D degree or other life science degrees (orequivalent);clinic practice is required.
2. Minimum 3 years of experience as physician or medical manager inbiopharmaceutical industry.
3. Rich working experiences in medical monitoring.
招聘人数:1