Position Summary Support clinical development planning and execution to align withcustomer’s clinical trial project request and quality standard.Byinteracting with various key functions (for example clinicaloperation,biometrics, quality assurance and pharmacovigilance), thisposition will provide clinical expertise to conduct and manage projectrelated medical monitoring. He/she shall deliver high quality clinicalscientific services by providing medical input to protocol, contributingto protocol adaptation, conducting medical writing, and relevantactivities. He / she shall also build and maintain good medical sciencerelationships internally with all functional lines within the companyand externally with KOLs and investigators. He / she will havetheexposure to different project teams, diverse portfolio of clients, aswell as various therapeutic areas.
Key Responsibilities 1. Assist company’s clinical development planning and execution. 2. Assist to oversee company*s overall clinical development activitiesinmedical 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 client’ 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 conductedperclinical development plan and all applicable regulations. 9. Act as the primary client’s 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 documentcontent.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.
Professional Experience & Education Requirement 1. Minimum M.D degree or other life science degrees (orequivalent);clinic practice is required. 2. Minimum 4 years of experience as physician or medical manager inbiopharmaceutical industry. 3. Rich working experiences in medical monitoring.