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Project Lead - FSP

Korea, Republic of, Remote Job ID R0000028801 Category Clinical Trials
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About this Role

Job Description

CORE JOB RESPONSIBILITIES

Global Clinical Research Area

  • Work in close and good collaboration with study team
  • Support or perform clinical feasibility study
  • Contribute to the selection of and negotiation with CROs
  • Coordinate the process for the selection of potential investigators considering capability, competence etc, of the center
  • Oversee site evaluation/selection, contracts/budget negotiation, regulatory/EC submissions, start up, issue management, relationship management, monitoring and site closure according to assigned role and responsibilities in each project.
  • Review and manage for the label of investigational product
  • Participate in initiation meeting to ensure CROs to give appropriate training to the relevant study staff and to put the procedure in place well
  • Perform regular quality oversight visits together with Study Team or alone and prepare oversight visit report timely
  • Proactively monitor study conduct and progress (e.g. study milestones, patient recruitment, protocol compliance, GCP/regulatory compliance etc.) with Study Team
  • Oversee clinical operation performance by CRO and proactively communicate with Study Team in order to give appropriate advice to them
  • Review of application/documents for submissions to regulatory authority and monitor clinical trial applications for obtaining rapid approval for trial commencement
  • Coordinate/support activities associated with audits and regulatory inspections
  • Ensure adherence to global regulations and local regulations, Good Clinical Practices (GCPs), ICH guidelines, DS standard operating procedures (SOPs), and to quality standards in conducting clinical research.
  • Prepare for and support publication (& publication material)

Administrative Area in Medical Division

  • Plan and manage budget for the assigned projects in accordance with compliance program and internal SOP
  • Cooperate to generate any documents with diligent efforts
  • Generate and revise internal local SOP in aligned with current activities
  • Provide information and update to CD team leader and other related departments about on‐ going and planned clinical studies/projects on a regular basis

Skills:

  • Good understanding of local regulations regarding safety reporting & promotional guidance documents
  • Proficient knowledge of computer software (e.g., MS Office Suite (Word, Excel, Power Point)
  • Effective interpersonal, communication, and presentation skills
  • Effective collaboration, project management skills
  • Good conflict management skills
  • Effective issue identification and problem‐solving skills
  • Ability to effectively prioritize workload
  • Professional and positive attitude; self-motivated to perform as a member of a high-performing team
  • Proficient in written and spoken English language required
  • Proficient in local language required

Knowledge and Experience:

  • Relevant work experience as a Clinical Research Associate (CRA) or minimum substantial relevant experience (preferably on-site monitoring experience)
  • Relevant Coordinating experience preferably obtained while working in a Senior CRA
  • Substantial experience in clinical research in Clinical functions with a potential to understand cross-functional activities related to data processing, data cleaning, and site management

Education:

  • Degree in a Life Sciences, Nursing, or other Medical Sciences


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