职位描述

职位描述： Position Purpose?The Data Management TA Lead in CDMM Shanghai provides functional area leadership, management of consistent harmonized processes, and implementation of excellence for CDMM deliverables related to high quality clinical trial data for clinical projects in a timely manner?Accountable for delivery of functional area goals?Provides functional leadership and management of strategies for the team specific implementation of technology-enabled processes?Participates with CDMM management, internal Pfizer global formulating strategies and standards to be implemented for all programs and to take responsibility for the implementation?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.Resources Managed (budget and FTEs)?Team consists of Pfizer Colleagues 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 COE, CO, DMM, CDQ and Programming groupsPrimary ResponsibilitiesGeneral?Provide administrative and data management technical and process oversight of team?Implements strategies to ensure the consistent processes in strong collaboration within CDMM, with Dev Ops global lines, and Alliance Partners?Participate in Dev Ops initiatives related to centralized services?Develop charters, resource utilization and project plans to achieve CDMM specific goals?Implements organizational design and develop succession planning for functional area in collaboration with other CDMM Leaders?Develop people, including recruitment, retention, and career development and performance managementSpecific?Ensures Conformance to Pfizer Data Standards?May participate in Therapeutic Area (TA) specific process improvement initiatives?Manages the DM team to CDMM metrics goals and resolve cross-functional barriers to achieving data management milestones?Actively oversees EPM project milestones and networks inconsistencies with stakeholders?Ensure appropriate resources are identified to support the portfolio?Ensure that all data activities are conducted in compliance with relevant regulatory requirements?Monitors and reports on implementation of functional area initiatives?Is accountable for the implementation of team CDMM data activities including Study Startup, Data Acquisition, Safety Data Management, Dictionaries, Standards and Discrepancy Management for clinical studies related to the drug programs?Implement data management strategies to ensure clear and transparent processes in strong collaboration with COE, CO,CPW, CDQ and Alliance Partners?Partner with other CDMM Team Leaders, CO, and Alliance Partners to promote the increased efficient use of EDC methods and technologies in clinical trials.?Partner with other CDMM Team Leaders, CO, and Alliance Partners to implement strategies to ensure speed and quality of data acquisition and data management, query resolution, data access and database release.?Partner with other CDMM Team Leaders, CO, and Alliance Partners to implement aligned strategies and consistent processes. This will optimize the use of corporate standards and achieve effective database knowledge sharing across the Development Continuum.Technical Skill Requirements?Demonstrated knowledge and success in managing multiple clinical programs, data acquisition and management technologies and processes.?Thorough understanding of Pfizer database and applications, Pfizer Data Standards (both data in and data out components).?Demonstrated ability to manage complex projects and processes. Established history of timely and quality delivery.?Demonstrated knowledge of clinical development and regulatory submission processes and requirements.?Demonstrated success/results in prior scientific/administrative management roles?Knowledge/proficiency/understanding of technologies to support data acquisition, computerization and data validation, computer systems life cycle technology; strong understanding of the state-of-the-art technologies to evaluate and leverage them into improved business processes for worldwide deployment and adoption.?Demonstrated platform skills; experience presenting to large scientific audiences and non-science populations?Understands and has demonstrated ability to manage large and complex budget; history of staying on or under budget.Qualifications (i.e., preferred education, experience, attributes)?Bachelor degree or equivalent in a natural/medical science, data management or related discipline.?Extensive clinical development and business experience in order to have a thorough understanding of the processes including data management and reporting.?History of achievement in a customer service role with demonstration of meeting customer needs and concerns. History of achievement in building strong customer relationships.?Strong technical knowledge of data management processes is required.?Extensive knowledge of vendor processes, contracting, and best practices in outsourcing are necessary. Must be capable to build strong relationships with application and service providers.?Leadership, project management, resource management (staff and financial), 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.?Experience supporting the data management components of regulatory submissions required.?Very strong skills in negotiation and conflict resolution essential. Ability to remain calm and focused in high-stress situations is very important.?Strong background in provision of high levels of Customer Service evidenced by positive feedback from customers.Preferred Additional Experience?Previous experience leading a substantial group responsible for clinical data management and/or clinical study 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 a plus.?Experience supporting the data management components of regulatory submissions required. 职能类别： 临床数据分析员

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