PRIMARY FUNCTION/OBJECTIVE 
Manage and lead a project on all aspects of design, planning, startup, conduct, analysis, reporting and 
closeout of assigned NIS including regulatory PMOS, IIS and medical operations. Responsible for managing 
planning, timelines, milestone, budget, study sites, vendors and deliverables while maintaining quality and 
compliance. Also, SMS will contribute to the pre-launch medical affairs initiative from medical operation 
perspective.

CORE JOB RESPONSIBILITIES 

• Provide comprehensive input to study concept development especially operational points of view. 
• Develop study protocol/protocol amendment and CRF and get approval from GUS-RC or ARC and MFDS (if 
• applicable) by managing multidisciplinary assessment. 
• Develop and provide official answers to MFDS by collecting and analyzing reference/data regarding 
• supplementary comments from MFDS (protocol, annual report, re-examination report) for regulatory PMOS. 
• Review and finalize CSR according to SOP and local regulation by coordinating and complying with all 
• internal processes and approvals as well as MFDS. 
•  MFDS point of contact: Communicate/Negotiate with MFDS on protocol/protocol amendment, study 
• implementation or issue for regulatory PMOS
• Study project management: Accountable for all aspects of project management including study plans, operation, coordination, timelines, problem identification and resolution, communication with stakeholders, status reports and budget forecasting/planning, CRO management to reach the milestone and to ensure timely delivery of completed study reports. 
  o Responsible for supervising daily operations and management of activities associated with assigned 
  project(s) from concept to completion of final study report and ensure project goals are achieved. 
  o Lead project start-up activities such as vendor evaluation, bidding, selection, set-up, and training as well as study site evaluation and selection 
  o Manage and steer vendors including CROs to perform studies as planned. 
  o Acts as a liaison with internal and external stakeholders regarding study update, issue escalation, study specific information, etc. 
  o Develop study budget plan, forecasting, review, reconciliation. Manage project specific budget by monitoring and adjusting current study status as well as evaluating FMV and ensuring investigator payments occur in a timely/compliant manner. 
  o Ensure effective project plans are in place and lead the project proactively with relevant stakeholders’ communication and to set priorities in accordance with applicable project plans.
• For IIS (Investigator Initiated Studies)/ IIP (Investigator Initiated Publication), manage and oversight as an 
  operational point, such as coordinate and support concept/protocol review and approval from All kinds of 
  Review Committee (Affiliate, Global, Area), FMV assessment, managing agreements, documents, milestones 
  (progress), payments, and issues 
• Assist in the initiation, oversight and follow up of assigned clinical studies and medical projects initiated 
  within the therapeutic area for which the SMS carries responsibility (e.g. post marketing clinical activities such 
  as, epidemiological surveys, post-authorization studies (phase IV). All such activities must comply with 
  applicable local laws, guidelines, codes of practice, SOPs, and AbbVie R&D (GPRD) SOPs. 
• Assure full compliance with GCP, Global & local SOPs, and Korean regulations.