职位描述

职位描述： Position Purpose?Technical Process Team Lead (TPTL) provides technical leadership and management in assigned functional areas, including but not limited to: Study Start Up, CRF building; Electronic Data Loading; Acquisition & Processing for Lab Data and PK/PD Data; Data extraction and listing for quality review, Data Visualization; EDC support; Randomization; and Coding, etc.?Accountable of delivery functional area goals, motivate and inspire staff, ensure alignment to agreed global and local Dev Ops strategic directions?Create, maintain and assume accountability for a culture of high customer service using tools to facilitate communication, transparency of operations, clarity of workload balance, and alignment?Identify, lead and support strategic initiatives within CDS to enhance operational efficiencies using systems and systems enabled processes.?Collaborate with other TPTLs to develop and maintain a support model and to facilitate issue resolution and capture corrective actions; and to ensure operational efficiencies such as resource sharing, staff development, and sharing of best practices across work areas, functions and sites.?Participate with other CDS Management and key customer leads to facilitate the delivery of services and effectively manage the coordination of services across specific process areas.Resources Managed (budget and FTEs)?Group consists of Pfizer headcount and contractors (this may vary depending upon workload requirements) locating at both SH and WH.?Manages relationships with Alliance Partners and electronic data vendor service providers.?Manages relationships with CII, CTPQ, DM and Programming groupsPrimary ResponsibilitiesProcess and Standards?Participate in standard forums (i.e., OPD zones, 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 needsTechnical 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?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： 生物工程/生物制药 技术支持/维护经理

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