Clinical Research Scientist

Description

The Clinical Research Scientist (CRS) leads the execution of the clinical studies that make up the company’s clinical evidence generation program. In this role, you will execute clinical studies and/or programs worldwide in accordance with strategy, project plans, approved budget and resource allocations following applicable regulatory and standard operating procedures.

The Clinical Research Scientist collaborates closely with cross-functional teams, including associate Clinical Research Scientists, Disease State Scientists, Biostatistics & Data Management, Logistics, Medical Writers, Regional Medical Affairs teams and other stakeholders to generate impactful clinical evidence that supports the company’s strategy. This role is crucial in maintaining our commitment to scientific excellence and patient-centric approaches within the competitive global healthcare landscape.

This position can be located in either St. Louis, MO OR Salt Lake City, UT.

• Leads the study team in the execution of clinical studies to meet the Evidence Generation Plan from study synopsis to data lock and final study report
• Partner with internal stakeholders to lead the development, review, and finalization of clinical protocols to meet regulatory and scientific objectives
• Contribute to the development of the study synopsis
• Partner with key stakeholders to create and manage the study execution team
• Collaborate closely with cross-functional teams including Regulatory Affairs, Quality Assurance, Biostatistics, Program Management, external vendors, and contract research organizations (CROs) to ensure high-quality study conduct
• Mentor Associate Clinical Research Scientist(s) and provide guidance on clinical operations processes, study management and other study execution tasks

• Develop and manage study budgets, timelines, enrollment strategies, and resourcing requirements to ensure study milestones are met
• Develop and manage all required plans including clinical study project plans, study execution plans, risk and risk mitigation plans, monitoring plan, and communication plans
• Contributes to or leads the development of abstracts/posters of study results in collaboration with study team
• Develop clinical study reports and/or contribute to the development of scientific publications

• Manage all aspects of clinical trial operations including study start-up, site initiation, patient enrollment, monitoring, and study close-out for bioMérieux initiated research studies and collaborative studies
• Track study progress and provide regular status reports to stakeholders