【新藥研發公司】Clinical Project Manager

仕事内容

• Proactively manage project level operational aspects including management of trial timeline, budget, resources, and vendors.
• Provide efficient updates on trial progress to the clinical 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.
• 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 procedures
• Effectively provide support to CRO/internal team/vendors in the conduct of the trials
• Support to development and review of SOPs and workflow