Associate Medical Solution Manager 医学事务解决方案副经理 (RWE & Study)-北京

The Medical Solution Manager is responsible for providing cost effective and innovative solutions to the development and needs of China Medical team in different areas, through engagement with a broader range of internal and external stakeholders, led by Pfizer and China Medical values.

The RWE and Study role of Associate Medical Solution Manager, will identify and prioritize RWE gaps, advise innovative RWE projects for different Categories; also as a statistics professional to supervise and provide statistical inputs or consultation to data management and statistical analyses for Pfizer sponsored or cooperative studies (such as NIS or RWS); and will be the facilitator to manage Pfizer sponsored post approval studies (nonregistration purposes) & Research Collaborations through coordination and cooperation with related internal and external stakeholders. All the above duties will be carried out under the guidance of China Medical Excellence/Operations Lead.

Real World Evidence:

• Interact with stakeholders to identify and prioritize data gaps and align with local Category teams and global RWE team on appropriate strategies and methods to meet those gaps.
• Identify and evaluate existing external databases and research partners for potential collaboration on RWE projects.
• Accountable as project consultant for coordination of design, planning and delivery of innovative RWE programs.
• Provide RWE-related academic support to internal and external stakeholders by coordinating multiple resources.

Statistics:

• From statistical perspectives to advise China Medical team on study design, data management, statistical analysis, interpretation of statistical results, and publications.
• Interact with third parties to supervise and provide statistical inputs to data management and statistical analyses and ensure timeliness and quality of statistical deliverables according to agreement in Pfizer sponsored post approval studies.
• Assistance with the development of statistics-related training courses led by ME&O team.

Study Management:

• Establishes the close cross-functional collaboration of all components of a study by working with study team members (including but not limited to Medical Advisors, Study Project Managers, Study Managers, Data Managers, Clinical Programmers, Medical Writers and Project Planners, Safety, Statisticians, Compliance Oversight, Regulatory and Medical QA) both internal and external to Pfizer to ensure studies deliverables.
• Develops working model for study (NIS or Research Collaborations) operation function in China Medical. Overall management on progress, quality, timeline, and budget to ensure all studies conducting smoothly and in accordance with SOP and good quality through leading the team in managing issues and driving for continuous improvement.
• Responsible for overall CRO management and site management to ensure study complied with GCP, SOP, company policy and regulations.
• Responsible for the development and ongoing management of contract and budget internally and externally.
• Creates effective, accurate and timely communication of project progress and issues to local and global   leadership. Guides local team in escalation pathways to ensure the issues resolving timely.
• Responsible for PCO, CCR, FCPA, and MQC review to ensure good compliance results. Leads the related trainings for Pfizer colleagues and CRO to ensure compliance.