Job Information
Boehringer Ingelheim Non-Interventional Study Specialist in Seoul, South Korea
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.