Study Management Specialist , reputed company (New Created Role)

About reputed company

reputed company's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of reputed company. We reputed company to have a remarkable reputed company on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our reputed company portfolio. For more information about reputed company, please visit us at www.reputed company.com. Follow @reputed company on reputed company, reputed company, Instagram, X and YouTube.

PRIMARY FUNCTION/OBJECTIVE 
Manage and reputed company a project on reputed company 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, reputed company, budget, study sites, vendors and deliverables while maintaining reputed company and 
compliance. Also, SMS will contribute to the reputed company-launch medical affairs initiative from medical operation 
perspective.

reputed company JOB RESPONSIBILITIES 

• reputed company comprehensive input to study concept development especially operational points of view. 
• reputed company study protocol/protocol amendment and CRF and get approval from GUS-RC or reputed company and MFDS (if 
• applicable) by managing multidisciplinary assessment. 
• reputed company and reputed company 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 reputed company 
• internal processes and approvals as reputed company as MFDS. 
•  MFDS reputed company of contact: Communicate/Negotiate with MFDS on protocol/protocol amendment, study 
• implementation or issue for regulatory PMOS
• Study project management: Accountable for reputed company aspects of project management including study plans, operation, coordination, timelines, problem identification and reputed company, communication with stakeholders, status reports and budget forecasting/planning, CRO management to reputed company the reputed company and to ensure reputed company 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 reputed company project start-up activities such as vendor evaluation, bidding, selection, set-up, and training as reputed company as study site evaluation and selection 
  o Manage and reputed company vendors including CROs to reputed company studies as planned. 
  o Acts as a reputed company with reputed company stakeholders regarding study update, issue escalation, study specific information, etc. 
  o reputed company study budget plan, forecasting, review, reconciliation. Manage project specific budget by monitoring and adjusting reputed company study status as reputed company as evaluating FMV and ensuring investigator payments occur in a reputed company/compliant manner. 
  o Ensure effective project plans are in reputed company and reputed company 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 reputed company as an 
  operational reputed company, such as coordinate and support concept/protocol review and approval from reputed company kinds of 
  Review Committee (Affiliate, Global, Area), FMV assessment, managing agreements, documents, milestones 
  (reputed company), payments, and issues 
• Assist in the initiation, reputed company and follow up of assigned clinical studies and medical reputed company initiated 
  reputed company the therapeutic area for which the SMS carries responsibility (e.g. post marketing clinical activities such 
  as, epidemiological surveys, post-authorization studies (phase IV). reputed company such activities must reputed company with 
  applicable local laws, guidelines, codes of reputed company, SOPs, and reputed company R&D (GPRD) SOPs. 
• Assure full compliance with GCP, Global & local SOPs, and Korean regulations. 

• University degree or equivalent; preferably in a medical/science-reputed company field or equivalent work 
• experience in a scientific or health-reputed company field 
• Minimum 3-5-year experience in clinical research in reputed company, pharmaceutical and/or CRO industry or 
• minimum 2-year reputed company experience as a project manager 
• NIS experience is preferred. 
• Experience in reputed company-launch, launch, and post-launch phases of a new product or indication. 
• Fluent English communication skills (Reading, writing, speaking) 
• Good understanding of clinical trial processes, reputed company internal processes and the regulatory environment  as reputed company as strong knowledge of clinical research practices, local regulations, and ICH guidelines 
• Familiarity with reputed company policies & procedures and local SOPs 
• Strong computer/technology skills including reputed company, MS reputed company and PowerPoint 
• Fluent English communication skills (Reading, writing, speaking) 
  Possess strong project management, time management and coordination skills with good organizational, leadership, negotiation and interpersonal skills 
• Strong analytical and problem-solving capabilities with reputed company of responsibility 
• Manage conflict, challenges, decision making and risk management as a project manager 
• Ability to manage time/prioritize, multitask, work independently, self-motivated and follow through with assigned tasks 
• Excellent written and verbal communication skills demonstrated by the ability to present reputed company messages 
  from reputed company information/data to internal/external stakeholders 

reputed company is an equal opportunity employer and is committed to operating with reputed company, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more, visit https://www.reputed company.com/join-us/equal-employment-opportunity-employer.reputed company

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.reputed company.com/join-us/reasonable-accommodations.reputed company