Clinical Research Scientist

bioMérieux•Hazelwood, MO

9d•$80,000 - $116,700

About The Position

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

Requirements

Bachelor degree required in scientific, medical, or healthcare discipline
2+ years of professional related experience in clinical trial management, preferably in diagnostics or medical device required.
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
Consistently upholds and reflects the core ethical principles and values that bioMérieux 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
Ability to manage budget, timelines and multiple projects simultaneously
Ability to learn new products and adjust to changing research directions

Nice To Haves

Certifications including ACRP-CP or ACRP-PM a plus.

Responsibilities

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 compliance
Lead internal and external study meetings with relevant stakeholders
Organize and drive study meetings and other study activities as assigned
Participate in core team meetings to provide clinical insights and contribute to strategic decision-making
Outline and communicate safety issues and planned mitigations in collaboration with internal stakeholders
Negotiate contracts and budgets in partnership with the legal team
Manage clinical trial agreements with external vendors
Manage vendor performance according to contract
Perform all work in compliance with company quality procedures and standards.
Perform other duties as assigned.

Benefits

A choice of medical (including prescription), dental, and vision plans providing nationwide coverage and telemedicine options
Company-Provided Life and Accidental Death Insurance
Short and Long-Term Disability Insurance
Retirement Plan including a generous non-discretionary employer contribution and employer match.
Adoption Assistance
Wellness Programs
Employee Assistance Program
Commuter Benefits
Various voluntary benefit offerings
Discount programs
Parental leaves