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· Work with Medical Writer to develop, review and finalize study protocols and reports, contribute to trial design, develop, review and revise IND/CTA documents, protocols, IB, CRF, ICF, IRB/EC documents, SAP, CSR and NDA documents
· Responsible and accountable for overall supervision/execution of medical validation/review of study data, including writing or supervision of study related documents (e.g.: medical monitoring plan, guidelines, etc…)
· Act as a key driver to assigned clinical projects, provide medical and scientific expertise to project teams, participate in project feasibility and risk assessment
· Help medical manager to prepare materials for investigator meetings, participate and present in investigator meetings, contribute to steering committees, data monitoring committees meetings, adjudication committees and prepare related material (e.g. charter, presentations)
· Conduct medical and safety monitoring, review clinical lab values, AEs/SAEs, coding dictionaries, assist with data safety monitoring board activities
· Maintain medical expertise in therapeutic domain
REQUIREMENTS
· Bachelor Degree or above in clinical medicine;
· Doctor’s license and at least 1 year work experience in a hospital, or at least 1 year work experience as a medical monitor
· Strong verbal and written English (equals to CEF B2, BEC V, IELTS 6.5)
· Good understanding of statistics and excellent interpretation and presentation skills, ability to accurately and clearly present clinical data
· Strong self-motivate, positive, energetic
· Ability to work independently, be able to work under pressure