职位描述

职位描述： Position Purpose?Provide subject matter expertise in the areas of technology and process being utilized within the strategic partnership model as they relate to the CDMS (Clinical Data Management) systems/Operations Support. ?Responsible for identifying and supporting strategic initiatives within Clinical Trial Solutions to enhance operational efficiencies using systems and system enabled processes. ?Provide support and escalation for operational services for Next Generation Clinical Trials Platform. ?Collaborate with other Subject Matter Experts within Pfizer , Alliance Partners, and other external vendors as appropriate.?Be able to bridge gaps between Pfizer and vendor systems for technical and process related troubleshooting and has the ability to easily transition from project to project as needed while maintaining connections to the innovation team and other external groups to Development Operations. The IM works across vendor systems, applications and processes.?Provide oversight and point of escalation to our niche providers as applicable. Help develop, maintain and improve processes associated with the Clinical System’s platform and operations support.?Partner with the Information Management teams regarding the Clinical Aggregation layer, ensuring Clinical systems/processes are consistent with the needs of the CAL.?Support and maintain all business related enterprise level activities regarding Pfizer’s use of the Clinical Systems platform and provide subject matter expertise and/or escalation support and guidance to CRDC, DJ and the Vendors.Organization Structure?This role will directly report to Shanghai – Team Manager, CTS.? Primary Responsibilities Process 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 organization Implementation? 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?Minimum 3-5 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： 临床数据分析员 系统分析员

联系方式