Project Lead - FSP
Seoul, Korea, Republic of Job ID R0000027503 Category Clinical TrialsAbout this Role
Job Description
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/documentsfor 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
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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