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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.

Primary Duties

Team and Cross Functional Leadership:
a. 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
b. Partner with internal stakeholders to lead the development, review, and finalization of clinical protocols to meet regulatory and scientific objectives
c. Contribute to the development of the study synopsis
d. Partner with key stakeholders to create and manage the study execution team
e. 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
f. Mentor Associate Clinical Research Scientist(s) and provide guidance on clinical operations processes, study management and other study execution tasks

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

Study Management and Site Management:
a. Manage all aspects of clinical trial operations including study start-up, site initiation, patient enrollment, monitoring, and study close-out for bioMerieux initiated research studies and collaborative studies
b. Track study progress and provide regular status reports to stakeholders
c. Assure study metrics and budget are input to corporate systems
d. Oversee site selection, feasibility, study startup, site activation, enrollment, and ongoing execution
e. Oversee clinical monitoring and data integrity
f. Update trial management systems, including timelines and budgets
g. Perform on-site and remote site qualification visits, site initiation visits, interim monitoring visits and site close out visits as required
h. 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
i. Manage and coordinate IRB/EC document creations and communications
j. Manage clinical trial agreements for sites
k. Manage study documentation and filing with electronic trial master file (eTMF) platforms

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

Quality and Compliance:
a. Identify and mitigate risks throughout the clinical trial lifecycle
b. Assure a quality plan is in place

Data Management:
a. Oversee and manage electronic data capture (EDC) systems
b. Oversee data collection activities, compliance, and inspection readiness
c. Oversee electronic trial master file (eTMF) platforms to ensure data integrity and regulatory compliance

Communication:
a. Lead internal and external study meetings with relevant stakeholders
d. Organize and drive study meetings and other study activities as assigned
e. Participate in core team meetings to provide clinical insights and contribute to strategic decision-making
f. Outline and communicate safety issues and planned mitigations in collaboration with internal stakeholders

Vendor management:
a. Negotiate contracts and budgets in partnership with the legal team
b. Manage clinical trial agreements with external vendors
c. Manage vendor performance according to contract

Perform all work in compliance with company quality procedures and standards.

Perform other duties as assigned.

Experience

• Bachelor's Degree required in a scientific, medical, or healthcare discipline
• 2+ years of professional related experience in clinical trial management, preferably in diagnostics or medical device required.
• Certifications including ACRP-CP or ACRP-PM a plus.
• Excellent knowledge of clinical trial processes, systems, and tools (e.g., CTMS, EDC, eTMF), with the ability to oversee quality, data integrity, and inspection readiness.
• Proven leadership and stakeholder-management capabilities, with the ability to influence without authority and build strong relationships across functions and with external partners.
• Experience negotiating clinical research contracts and budgets
• Knowledge of Good Clinical Practice ICH/GCP and other applicable regulations, fundamental knowledge of clinical research and monitoring requirements
• Experience managing all major aspects of strategic planning, organization, implementation, and delivery of clinical studies.
• Understanding the US and European Medical Testing environments and relevant professional societies and guidelines (e.g. FDA, CE-Mark IVD Directives, CAP, CLIA, WHO)
• Proven track record writing clinical study plans and study protocols
• Experience with the study budget oversight, risk mitigation, management of timelines, deliverables, and milestones
• Experience negotiating clinical research contracts and budgets with Investigators and sites
• Experience with electronic clinical trial systems and clinical data review

Knowledge, Skills, & Abilities

• Consistently upholds and reflects the core ethical principles and values that bioMerieux promotes.
• Ability to work cross-functionally allowing for better collaboration and communication when working across teams to achieve shared objectives
• Effective Presentation Skills - including the ability to present technical data
• Solution oriented in the face of conflict
• Practicing time management to allocate tasks, balance priorities, and meet deadlines efficiently
• Managing and measuring work by tracking progress, performance, and goal achievement using metrics and KPIs.
• Skilled in MS Office tools to include but not limited to Outlook, Teams, Word, and Excel
• Advanced: demonstrates deep knowledge; manages complex tasks and integrates multiple tools independently
• Functionally Required Knowledge, Skills, and Abilities
• Ability to manage budget, timelines and multiple projects simultaneously
• Ability to learn new products and adjust to changing research directions