Clinical Development Scientist overseeing global clinical trials for vaccine programs. Responsible for design, oversight, data integrity, and collaboration with operational teams.
Responsibilities
Provide clinical and scientific oversight and support for multiple, global Phase 1 - 4 clinical trials.
Responsible for the design, scientific oversight, data integrity and quality of the clinical trial(s).
Author protocols, study level informed consent documents, and contribute to authoring clinical study reports and regulatory responses.
Partner with other clinical colleagues, clinical operations and other functional lines for successful implementation of clinical trial(s).
Lead clinical input for study setup and design, including data tools and analysis.
Review and query trial data in support of clinical data review strategy.
Requirements
PhD/PharmD and 2+ years' experience in a vaccines clinical scientist type role OR MA/MBA/MS and 5+ years clinical development experience including 2 years of experience in a clinical scientist type role.
Proven track record executing vaccine development programs to completion or targeted milestone.
Strong clinical research background and Good Clinical Practices experience.
Vaccines development experience.
Experience integrating and summarizing 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.
Working knowledge of statistics, data analysis, and data interpretation.
Exceptional written and oral communication and cross-functional collaborative skills.
Proficient in MS Word, Excel, and PowerPoint.
Benefits
Health benefits to include medical, prescription drug, dental and vision coverage.
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