PM/临床项目经理 - Phase IV项目

该职位来源于猎聘 FSPxTop Global Pharma, 负责上市后四期项目 要求：1年以上PM工作经历，有global平台工作背景，prefer有肿瘤项目经验 & 上市后管理经验的，也open看上市前项目管理经验的候选人，英语workable JOB SUMMARY Provides customer-focused leadership in managing clinical projects across various phases, functional areas and assigned clinical staff. Accountable for the successful execution of all assigned projects, where success includes on-time, on-budget, high-quality/compliant project results that lead to satisfied customers. May have line management responsibilities. JOB RESPONSIBILITIES Project Leadership and Delivery:

• Manages a project as a project manager overseeing interdisciplinary clinical research studies and ensures compliance with GCP, relevant SOP’s, and regulatory requirements.
• Acts as a primary liaison between the Company and the Customer to ensure timely study launch, conduct, and closeout according to the Customer’s and the Company’s contractual agreement.
• Lead project team to ensure quality, timelines and budget management.
• Accountable for the financial performance of each project.
• Coordinate activities and deliverables of all study conduct partners and proactively identify and manage issues.
• Ensure studies are conducted in compliance with GCP, relevant SOP’s and regulatory requirements.
• Accountable for all project deliverables for each project assigned. Documentation and Reporting:
• Responsible for quality and completeness of TMF for assigned projects.
• Accountable for maintenance of study information on a variety of databases and systems.
• Responsible for study management components of inspection readiness for all aspects of the study conduct.
• Oversight for development and implementation of project plans.
• Plan, coordinate and present at internal and external meetings.
• Prepare project management reports for clients and management.
• Developing contingency planning and risk mitigation strategies to ensure successful delivery of study goals. Management:
• May be required to line manage other project management team members and clinical monitoring staff. QUALIFICATION REQUIREMENTS
• Bachelor’s Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or equivalent combination of education and experience.
• Clinical research organization (CRO) and relevant therapeutic experience preferred. Strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements
• Strong organizational skills.
• Strong ability to manage time and work independently.
• Direct therapeutic area expertise.
• Ability to embrace new technologies.
• Excellent communication, presentation, interpersonal skills, both written and spoken.
• Ability to travel as necessary (approximately 25%).