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Project Lead - Fsp, Korea South

Korea South, Korea South, Korea South
게시됨 2024-07-04
만료 2024-08-04
ID #2225496408
Free
Project Lead - Fsp, Korea South
Korea South, Korea South, Korea South,
게시됨 July 4, 2024

설명

When our values align, there's no limit to what we can achieve. Job Description[1] Global Clinical Research Area Work in close and good collaboration with Global Study Team Identify candidate investigators considering qualification, experience, etc.

Engage in feasibility and site selection process Support to the selection of vendors including CROs, if required Oversee overall clinical trial status including contracts/budget negotiation, regulatory/EC submissions start up, issue management, relationship management, monitoring and site closure, data management according to assigned role and responsibilities in each project.

Review and manage the label of investigational product in collaboration with RA team.

Participate in the investigator’s meeting and 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 through e TMF functional QC, reviewing MVRs, CRO oversight visit, etc.

Proactively monitor study conduct and progress (e.g.

study milestones, patient recruitment, protocol compliance, GCP/regulatory compliance etc.)Oversee clinical operation performance by CRO and proactively communicate with Study Team to improve the quality.

Manage KEEs with clinical science knowledge Prepare clinical trial documents or provide the relevant information to RA team for submission to regulatory authority for IND related work.

Manage issues proactively through trouble shooting in collaboration with relevant stakeholders.

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 Plan and manage budget for the assigned projects in accordance with internal instruction/policy 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 / SKILLSWillingness to communicate with global stakeholders through TC, etc.

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

작업 세부 정보:

직업 종류: 풀 타임
계약 유형: 영구적인
급여 유형: 월간 간행물
직업: Project lead - fsp

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