at Pfizer, Inc in Bentonville, Arkansas, United States
The Clinical Development and Operations (CD&O) Clinician is accountable for the medical & scientific integrity of the study and the well-being of the patients enrolled in one or more clinical trials. The role applies technical and clinical/medical skills to ensure the design of efficient and high quality clinical trials, employing quantitative design principles (including MIDD), and clinical best practices to deliver both clinical and operational excellence.
Responsible for effective execution of studies and works in close partnership with Clinical Operations team members. The CD&O Clinician is accountable for timely delivery of a quality protocol, clinical execution of one or more large and / or complex clinical trials and supports appropriate interpretation and communication of clinical trial data.
The CD&O Clinician maintains compliance with internal and external standards, proactively mitigates risk and manages emerging clinical issues through timely, diligent clinical data, safety and protocol deviation review. Performs medical monitoring of one of more clinical trials.
The CD&O Clinician will also be the primary contact with external investigators & the internal study team for questions relating to clinical/medical aspects of the protocol.
May also provide matrix management support of one or more CD&O clinicians on one or more clinical studies or across a clinical program.
Autonomously and independently leads clinical execution of one or more studies of medium - high complexity and significant business impact. May be accountable for program level clinical deliverables.
Provides CD&O input to support development of the protocol design document. Leads development of the protocol from the approved PDD and ensures efficient protocols which maximize operational efficiency, trial quality and participant / site engagement and which minimize the likelihood of amendments or quality issues.
Partners with Category Clinical function in governance review and approval process.
Provides clinical input to the DORA process to ensure application of data standards, optimized data collection and both timely and thorough review of data through the use of clinical data review best practice. Responsible for providing CD&O clinical input to SAP, TLFs and BDR.
Authors and manages approval of Informed Consent Documents (ICDs) including responses to external stakeholder questions.
Provides clinical input to development of the Integrated Quality Management Plan (IQMP). Review and approves final document.
Accountable for establishing Data Monitoring Committees (DMCs) and endpoint adjudication committees, including chartering, contracts, provision of relevant data and documentation of outcomes.
Inputs to, reviews and approves, Risk Management and Safety Review Plan. Ensures activities are conducted consistent with the approved plan and partners with key stakeholders (clinical operations, safety risk lead etc) to develop and implement any risk mitigations.
Reviews and approves country selection, develops site selection criteria and ensures protocol specific training. Approves investigator meeting plans.
Serves as the primary contact with external investigators and internal study team for questions relating to clinical aspects of protocol
Reviews, reports and manages protocol deviations and approves protocol amendments.
Reviews patient level and cumulative data per the data review plan across one or more studies.
Reviews safety data, SAE reports, TME's, DME's and ensures clinical documents (eg ICD) are updated as required. Tracks and reconciles serious adverse events (SAEs) across a study and leads presentation of data during Safety Review Team meetings.
Acts as the medical monitor on one or more clinical trials.
Ensures TMF compliance for CD&O clinical documents
Inputs and reviews the Clinical Study Report including the review of narratives. Responsible for supporting disclosure of safety and efficacy data and trial conclusions. Contributes to primary publication of clinical trial results.
Provides clinical support to the study team or clinical program in response to audits or inspections, including providing support as needed to audit/inspection May contribute to clinical sections of regulatory filings (Paediatric Investigational Plan, Investigator... For full info follow application link.
EEO & Employment Eligibility:
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.