职位描述

职位描述： Process and Standards?Participate in standard forums (i.e., CDS initiatives, etc.) to further standardize and optimize CDS’s processes and practices?Actively identify continuous improvement opportunities to enhance operational efficiencies through process and metrics analysis?Participate and lead efforts to develop processes, standards and training as they relate to the technology-enabled clinical trial processes?Promote the use of consistent, efficient, and quality processes to meet timelines and deliverablesCustomer Outreach?Plan and execute communication plans & methods for engaging customer populations (e.g., newsletters, websites, user groups)?Interface with customers on solutions, requirements, continuous improvement, deployment change management, user groups and workshops, etc?Understand customers and stakeholders and ensure they are satisfied with support services and systems?Build & maintain knowledge-base (e.g., FAQ)?Communicate key project status and to various levels within the organizationImplementation?Implement business strategies and technology-enabled processes and tools in close partnership with appropriate groups in Development and Informatics (including Business impact assessments and AIM deliverables)General?Provide administrative and technical oversight of group?Develop people, including recruitment, retention, and career development and performance management?Able to resolve conflicts, influence and communicate with key stakeholders and user groups?Collaborate with key departments both at Pfizer and Alliance Partners?Support rapid response, audit and inspection needs?Portfolio management for Pfizer products development?Resource management for demand and actual headcount?Metrics for business operation?Process development, implementation and oversight?Compliance oversight at departmental level?Quality oversight and implementation?pTMF related tasksTechnical Skill Requirements?Technical expertise and business process support in systems supporting clinical trials (document management, data acquisition, data management, trial management, reporting, etc)?Thorough understanding of the processes associated with clinical study management, data management, and regulatory operations?Leadership, project management, resource management (staff), administrative, and technical capabilities are required, as well as effective verbal and written communication skills in relating to colleagues and associates both internal and external to the organization.?Demonstrated project management skills (multiple complex projects)Qualifications (i.e., preferred education, experience, attributes)?Bachelor’s degree or above of equivalent experience in a scientific discipline requiredPreferred Additional Experience?Previous experience leading a substantial group responsible for any technical operations or clinical data management function, or equivalent.?Leadership, project management, resource management (staff and financial), administrative and technical capabilities are required, as well as effective verbal and written communication. International experiences are a plus.?Experience supporting the data management components of regulatory submissions required. 职能类别： 医疗器械生产/质量管理

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