Seoul, KOR
2 days ago
Non-Interventional Study Specialist
**THE POSITION** + _Lead the medical study projects with ownership, such as ONIS for PMS/RMP, OS, CUP and_ _IIS in accordance with applicable law and regulation._ + _AS mandated by regulation, rPMS should be in compliance to relevant local regulations_ _and guidelines as well should be managed in line with relevant SOPs._ _OS also should be_ _conducted in accordance to latest relevant regulation, guidelines and SOPs._ _Full_ _support for the CUPs and IISs according to relevant guidelines and SOPs needs to be_ _provided so that the projects can be conducted without quality issue._ **Tasks & responsibilities** + _Responsible for oversight, management and operational_ _activities aligned with applicable law and regulations._ + _Managing overall process(planning, operation,_ _completion and HA reporting) of ONIS for PMS/RMP, OS,_ _CUP and IIS studies._ + _CRO management - selection, quotation, contract,_ _oversight and payment._ + _Managing overall project budget - investigator fee,_ _CRO fee, PTC. Budget planning and execut_ _e_ _actual payments according to planning_ + _Health Authority (HA) and IRB management_ _- Managing HA and IRB stakeholders to maintain studies. Prepare and report related documents/communicate for study related issue_ + _Overall study management with strategic plan – project set up, operation, finalization_ **Requirements** + _Bachelor's degree and above in Pharmacology, Nursing and Bioscience, etc._ _preferred._ + _At least 5_ _years experience of project management_ + _Good project management skill, ownership and accountability_ + _Highly committed to planned milestones_ + _English : Fluent proficiency in reading and interpretation. Professional working proficiency in writing and speaking._ + _Excellent communication skills with various stakeholders_ + _Strategic thinking and planning skills._ + _Computer literate, MS word, excel etc. and similar software_ All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
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