Clinical Research Scientist

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 also be located in Salt Lake City, Utah or Durham, North Carolina.

• 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.
• Assure study metrics and budget are input to corporate systems.
• Oversee site selection, feasibility, study startup, site activation, enrollment, and ongoing execution.
• Oversee clinical monitoring and data integrity.
• Update trial management systems, including timelines and budgets.
• Perform on‑site and remote site qualification visits, site initiation visits, interim monitoring visits and site close‑out visits as required.
• Oversee clinical site activities, reference laboratories, CROs, and other external partners to ensure adherence and compliance with protocol timelines, budgets, study milestones and quality standards.
• Manage and coordinate IRB/EC document creations and communications.
• Manage clinical trial agreements for sites.
• Manage study documentation and filing with electronic trial master file (eTMF) platforms.

• Follow Corporate (e.g., SOP’s) and local/regional regulatory requirements.
• Participate in the review and revision of Clinical Operations Standard Operating Procedures (SOPs) to assist Medical Affairs leadership with continuous process improvement initiatives.

• Identify and mitigate risks throughout the clinical trial lifecycle.
• Assure a quality plan is in place.

• Oversee and manage electronic data capture (EDC) systems.
• Oversee data collection activities, compliance, and inspection readiness.
• Oversee electronic trial master file (eTMF) platforms to ensure data integrity and regulatory…