职位描述

职位描述： Primary ResponsibilitiesProcess and Standards? Interface with CDQ organization, Business Process Owner Network and other COE colleagues to further standardize and optimize Pfizer’s processes and practices? Actively identify continuous improvement opportunities for the team to enhance operational efficiencies through process and metrics analysis? Participate in 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) in coordination with the IM Communication group.? Interface with customers on solutions, requirements, continuous improvement, deployment changemanagement, user groups and workshops, etc.? Understand customers and stakeholders and ensure they are satisfied with support services andSystems? Build & maintain knowledge-base (e.g., FAQ)? Collaborates with IM Centralized Services as appropriate? 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 COE, CRDC, GCTE, Japan, Vendors (including business impact assessments and AIM deliverables)? Assist Team Manager to oversee vendors across various needs (e.g., Tier 1 services, quality management, data management, study start up, electronic data, etc)? Assist Team Manager to define scope of outsourced work and establish work instructions / task ownership matrices /escalation paths / SLAs for vendors providing services to IM-CTS? Assist Team Manager to establish oversight plans and metrics associated with outsources servicesGeneral?Provide expertise in technology and process being utilized within the strategic partnership.?Demonstrate the ability to follow information flow between vendor and Pfizer systems.?Actively identify and bridge gaps between Pfizer and Partner systems for technical and process related issue management.?Easily transition from project to project as needed while maintaining connections to the innovative team and other external groups to Development Operations.?Work across Partner systems, applications and processes. Interact with and support CRDC and Japan as it related to eClinical suite?Collaborate with business process owners and information technology, as appropriate, to support potential changes or improvements related to systems and processes.?Manage queries from the organization related to technology and processes.?Be able to resolve conflicts, influence and communicate with key stakeholders and user groups.?Support rapid response, audit and inspection needs.?Work proactively with Training representatives to develop training strategy including recommending curricula assignments, materials development and communications required to support the roll out of revised processes.Technical Skill Requirements?2-5 years’ experience in the clinical trial process is strongly desired?Knowledge of information system management and change control processes, application validation and implementation in a GxP environment?Knowledge of Pharmaceutical metadata and standardsQualifications (i.e., preferred education, experience, attributes)?Minimum of Bachelor's Degree in life sciences, information management/technology. MS Computer Science desired.?Demonstrated in depth knowledge of Pharmaceutical drug development environment and regulations.?Ability to interact in a professional manner and build strong collaborative relationships with internal Pfizer teams.?Ability to interface with international colleagues, understand the “big picture” in terms of potential implications of changes to systems and processes to sites and/or affiliates outside of home country/region?Strong demonstrated project management and technical capabilities?Strong verbal, written communication and presentation skills. 职能类别： 医药技术研发管理人员

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