(Associate) Clinical Project Manager 臨床專案經理

• Proactively manage project level operational aspects including management of trial timeline, budget, resources, and vendors. • Provide efficient updates on trial progress to the Clinical Director and/or Senior management team, with respect to vendor selection, project plans, trial budget and timeline management, quality standards and risk mitigation. • Lead sponsor 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. • Ensure effective project plans are in place and operational for each trial and work proactively with the internal team/vendors to set priorities in accordance with applicable project plans, company standard operational procedures (SOPs), ICH/GCP guidelines and regulatory requirements. • Ensure potential study risks are escalated to the attention of the Clinical Director when appropriate. • Chair internal working group 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 with internal team/CRO. • Monitor the quality of vendor deliverables, address quality issues with the appropriate team member and identify opportunities to improve training, execution and quality control across the clinical team. • Review and approve vendor invoices to ensure payments occur in a timely manner • 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 internal team/vendors regarding TMF filing, maintenance and archival procedure • Effectively provide support to CRO/internal team/vendors in the conduct of the trials • Support to development and review of SOPs and workflow