모집분야: 임상 CPM / Sr. CPM(과장~부장)|
- 경력 : CPM 경력 2년 이상
- 전공 : 간호학/약학/생물학 전공자(4년제 대졸 이상)
• 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 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 team leader/relevant teams when appropriate.
• Collaborate communications with internal/external project team members
• 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.
• 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 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
지원서류: 이력서, 경력기술서