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
Requirements
- Bachelor's Degree in a scientific, medical, or healthcare discipline
- 2+ years of professional related experience in clinical trial management, preferably in diagnostics or medical device
- 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
Nice to Have
- Certifications including ACRP-CP or ACRP-PM
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
Work Arrangement
Remote (City/Region)
Additional Information
- This role is eligible to receive a variable annual bonus based on company, team, and individual performance per bioMerieux’s bonus program.
