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Project Lead(FSP)

Parexel International Corporation

Korea, Republic of, Remote

Project Lead (FSP)

CORE JOB RESPONSIBILITIES

[1] 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)

[2] 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

COMPETENCIES / SKILLS

  • Good understanding of local regulation regarding safety reporting & promotional guide
  • Good ability in working according to global standards
  • Good written and spoken English capabilities
  • Good knowledge of computer software
  • Good interpersonal skills and communication skills
  • Good collaboration skills
  • Good conflict management skills
  • Good project management skills
  • Good presentation skills
  • Good change management skills
  • Issue identification and Problem‐solving skills
  • Ability to give prioritize tasks
  • Active and open‐minded person to handle multi tasks in the department
  • Professional and positive attitude
  • Have strong agility for the self‐motivation/development to be a member of high‐performing team

Job posted: 2023-05-17

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