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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