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You will provide clinical and scientific oversight and support for multiple, global Phase 1 - 4 clinical studies in support of the development strategy for programs within the Vaccines portfolio.
Job Responsibility:
Maintains current scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment
Responsible for the design, scientific oversight, data integrity and quality of the clinical study
Authors protocols, study level informed consent documents, and contributes to authoring of site training materials, clinical study reports, regulatory responses, and other clinical and regulatory documents
Partners with other clinical colleagues, clinical operations and other functional lines for the successful implementation and execution of the clinical studies within the assigned program
Leads clinical input for study setup and design, including data tools, analysis, and database setup
Contributes to the Statistical Analysis Plan and clinical data outputs
Reviews and queries study data in support of the clinical data review strategy and collection of quality data and review of emerging clinical data and trends, presents and discusses relevant data to appropriate teams, and other internal/external stakeholders
Analyzes the emerging safety profile of the drug, keeping the clinical and safety colleagues informed of changes in the safety profile as they occur in the assigned trial(s)
Follows relevant SOPs and regulations, has an excellent understanding of and complies with applicable trainings, seeks opportunities to further improve quality and efficiency of clinical procedures
leads or actively participates in portfolio- and enterprise level workgroups aimed at optimizing PFE clinical development procedures
may be a subject matter expert or business process owner for a relevant SOP or procedure
Requirements:
BA/BS Degree in a science or health-related discipline
A strong clinical research background and Good Clinical Practices experience
Working experience of vaccines therapeutic area
Ability to integrate and summarize medical/scientific concepts in protocols and documents
Proven record of independently writing clinical protocols and study documents
Experience participating in and informally leading an operational team
Process improvement experience
Has working knowledge of statistics, data analysis, and data interpretation
Exceptional written and oral communication and cross-functional collaborative skills