[담당업무] • Participate in overall Clinical Development Planning for Products, clinical protocol development and other relevant clinical study document
development, if required.
• Proactively manage project level operational including management of trial timeline, budget, resources and vendors.
• Provide efficient updates on trial progress to the Global Project Manager (gPM)/COL, with respect to vendor selection, project plans, trial budget
and timeline management, quality standards and risk mitigation.
• Lead study startup process, including but not limited to conduct of the Trial Kick-off meeting, the set-up of trial master file (TMF), site selection and
finalization of site and vendor Clinical Trial Agreements and budgets, if required.
• Lead and track on recruitment performance of assigned projects/countries and project team members with proactive leadership and ensure other
effective project plans are in place and operational for each trial and work proactively with the project team to set priorities in accordance with
applicable project plans, company standard operational procedures (SOPs), ICH/GCP guidelines and regulatory requirements.
• Check the identified risk, set up the mitigation plans, review actions taken and control risk in risk management plan for assigned projects/countries
and ensure potential study risks are escalated to the attention of the gPM/COL when appropriate.
• Collaborate communications with internal/external project team members
• Support Data Safety Management Board (DSMB) set up, DSMB charter, archiving of documentation, follow up actions
• Lead project team meeting and vendor status update meetings and ensure meeting minutes are completed, distributed to team members and
filed in the Trial Master File (TMF) in a timely manner.
• Review and approve site visit reports; ensure tracking, follow up and resolution of site issues have been completed in a timely manner, if required.
• Monitor the quality of vendor deliverables, address quality issues with the appropriate team member and identify opportunities to improve training,
execution and quality control.
• Review and approve vendor invoices in collaboration with the Accounting team to ensure investigator payments occur in a timely manner and
report to gPM/COL
• Review and approve vendor responses to quality assurance audits for appropriateness, timeliness and accordance with company SOPs and
regulatory requirements.
• Ensure all project level study documentation is filed in the TMF in accordance with company SOPs/all regulatory requirements and provide
oversight to the clinical team regarding TMF filing, maintenance and archival procedures
• Effectively provide support to CRO Team Members and Clinical Sites in the conduct of the trials
• Keep balance between strategic plans and clinical research activities for assigned projects/countries
[근무부서 및 직급/직책] | [자격요건] 경력사항: 경력(5년 이상 )
학력사항: 대학교(4년)졸업 이상
직무기술: 임상
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