? 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 (or elements of those studies).
? Provides clinical and scientific expertise to the clinical trial strategy and protocol development process, including acquisition of knowledge of competitor products.
? Through application of Enhanced Clinical Trial Design (ECTD)/ Enhanced Quantitative Drug Development (EQDD), ensures the most efficient clinical protocols are developed.
? Designs/writes clinical trial outlines, protocols and amendments, in collaboration with internal contributors (e.g. statisticians, Outcomes Research (OR) specialists, clinical pharmacologists, clinical project managers, Regional Clinical Site Leads (RCSLs), market access colleagues, commercial development colleagues), internal experts (e.g. clinical program lead, global clinical lead, global clinical strategy lead), and external experts (e.g. investigators, key opinion leaders, advisory board members)
? Creates (and where appropriate, delivers) clinical/protocol training materials for study and site management and for use during site initiation visits and investigator meetings.
? Helps establish and oversees Data Monitoring Committees (DMCs) and endpoint adjudication committees, including chartering, contracts, provision of relevant data and documentation of outcomes.
? Jointly accountable with study team for study enrollment and adherence to agreed timelines for study deliverables.
? Maintains direct contact with investigative sites through site visits, telephone contacts, email etc., in order to facilitate investigator engagement, address investigator questions regarding the protocol or the investigational product, and support enrolment activities. This is done in conjunction with RCSLs (when assigned) for sites outside US, Canada, Japan and China. For some studies the clinician may take on an expanded role as described below for the site liaison responsibilities.
? Consistent with Safety Review Plan (SRP), performs and documents regular review of individual subject safety data and cumulative safety data with the safety risk lead (as delegated by the China Clinical Program Lead or the Global Clinical Lead). For all studies, clinical safety review should be performed in consultation with a designated medically qualified Medical Monitor.
? Responsible for identifying emerging safety trends and raising them forward for further discussion with the Clinical Program Lead and/or Global Clinical Lead; follows up with investigators for specific safety findings (e.g. SAEs).
? Reviews and manages protocol deviations.
? Works with study team to ensure high quality of data, e.g. appropriate patient population, adequacy of clinical assessments etc., as study is ongoing.
Site Liaison Responsibilities (if applicable)
The China Clinician may have site liaison responsibilities:
? Serve as clinical site liaison to support trial conduct through virtual meetings or teleconferences (as appropriate) and essential face-to-face contact, working directly with site staff. Maintain the ‘Face of Pfizer’ at each site. Create and maintain positive relationships and enthusiasm.
? Understand the work environment and key relationships at clinical sites, use analytical and influencing skills to improve communications and collaboration between key stakeholders.
? Ensure site staff have thorough understanding of protocol requirements (technical and logistic), partner with site staff and study team members to overcome feasibility barriers and operational obstacles and ensure successful subject recruitment/enrollment/retention, protocol compliance and clinical trial quality.
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? Conduct frank discussions and set clear expectations for site performance and monitor site performance through metrics.
? Identify quality issues and discuss with Pfizer clinical/operations study team members so that corrective actions may be instituted. Escalate protocol-related issues requiring medical expertise to the RCSL or medically qualified China Clinical Program Lead, if needed. Escalate operational issues to the appropriate operations study team member.
? Identify the need for and provide supportive coaching and/or training to site staff, as appropriate.