Responsible for the successful planning, implementation and execution of clinical study (ies) to verify and validate new clinical software, instrument platforms, assays and biomarkers developed by RMS. Functionally responsible for all clinical monitoring activities throughout the duration of each clinical trial. Assures clear external/internal team communication, process documentation, and compliance with Good Clinical Practices and procedures set forth.
7+ years of experience in clinical trials is required, 9+ preferred
Experience in diagnostics, biotechnology and/or pharmaceutical clinical research with responsibilities for managing all major aspects of strategic planning, organization, implementation, and delivery of clinical programs.
Knowledge, Skills, and Abilities:
Demonstrated ability to work collaboratively across all levels of an organization and to lead influentially
Ability to operate and lead efficiently in a heavily matrixed and multi-site organizational structure.
Understands the US and European Medical Testing environments and relevant professional societies and guidelines (e.g. FDA, CE-Mark IVD Directives, CAP, CLIA, WHO, IASLC, ASCCP, etc.).
Excellent knowledge of applicable standards and regulations for clinical trials and laboratory conduct (CFR, ICH-GCP, Federal guidelines, GMP, GLP, ISO, etc.)