# Development China Clinician **Company**: Pfizer **Experience**: senior **Job type**: full-time **Category**: Healthcare **Industry**: Healthcare **Apply**: https://pfizer.wd1.myworkdayjobs.com/en-US/PfizerCareers/job/China---Shanghai---STIT/Onco-Clinician--Contractor--Shanghai-Beijing_4960380?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply **Canonical**: https://yubhub.co/jobs/job_bb180b0a-870 ## Description The Development China Clinician is responsible for high-quality and timely delivery of one or more interventional clinical trials for R&D. They apply technical excellence in the design of cost-efficient clinical trials to meet the needs of internal and external customers, ensure effective conduct and medical/scientific oversight of studies, and support appropriate interpretation and communication of clinical trial data. Responsibilities: - Co-chairs clinical study team and works collaboratively with other study team members. - Point of accountability to the BU for design, conduct, interpretation, and reporting of one or more clinical studies. - Provides clinical and scientific expertise to the clinical trial strategy and protocol development process. - Designs and writes clinical trial outlines, protocols, and amendments. - Proactive in authoring efficient protocols that minimize the likelihood of amendments. - Identifies and assesses study risks to good clinical practices, subject rights/safety, and data integrity. - Provides clinical input to Study Team for monitoring guidelines, statistical analysis plans, informed consent documents, and clinical review forms. - Contributes to CRO/vendor selection to ensure study is conducted consistent with protocol requirements. - Approves selection of countries, clinical sites, and investigators. - Ensures study is registered on www.ClinicalTrials.gov and study details are kept up-to-date. - Creates clinical/protocol training materials for study and site management. - Helps establish and oversees Data Monitoring Committees (DMCs) and endpoint adjudication committees. - Jointly accountable with study team for study enrollment and adherence to agreed timelines for study deliverables. - Maintains direct contact with investigative sites. - Performs and documents regular review of individual subject safety data and cumulative safety data. - Responsible for identifying emerging safety trends and raising them forward for further discussion. - Reviews and manages protocol deviations. - Works with study team to ensure high quality of data. - Conducts clinical review and interpretation of efficacy and safety data from clinical trials. - Responsible for clinical and scientific validity of study report. - Ensures narrative strategy for clinical trial(s) is consistent with program narrative strategy. - Assists in ensuring regulatory compliance for clinical trials and reporting. - May act as primary contact with external investigators and internal study team. - Responsible for keeping the Development China Clinical Program Lead and/or Development China Category Development Lead informed of any critical issues. - Presents to internal and external advisory committees on design of clinical trials and data from clinical trials. Site Liaison Responsibilities (if applicable): - Serve as clinical site liaison to support trial conduct. - Understand the work environment and key relationships at clinical sites. - Ensure site staff have thorough understanding of protocol requirements. - Conduct frank discussions and set clear expectations for site performance. - Identify quality issues and discuss with Pfizer clinical/operations study team members. - Identify the need for and provide supportive coaching and/or training to site staff. General: - Motivates and engages colleagues in an understanding of disease and commitment to an indication and mechanism. - Coaches and mentors less experienced clinicians. - Maintains and enhances knowledge in relevant disease area and/or technical area. - Interfaces with other Pfizer sites, other BUs, and other functions to develop and share best practices. ## Skills ### Required - clinical trials - medical oversight - regulatory compliance - data analysis - protocol development --- Source: [Apply at pfizer.wd1.myworkdayjobs.com](https://pfizer.wd1.myworkdayjobs.com/en-US/PfizerCareers/job/China---Shanghai---STIT/Onco-Clinician--Contractor--Shanghai-Beijing_4960380?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)