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.