We are seeking a Clinical Operations Manager for a client with offices in Pleasanton, CA
This will be remote at first until COVID restrictions are lifted.
1 year contract
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 the company. 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 GCPs and procedures set forth.
- Bachelor degree in scientific discipline or related field required.
- 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.
- 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.)
- Ability to initiate and effectively lead change efforts, and ensure people accountability.
- Strong communication, presentation, and interpersonal skills and ability to build close working relationships across the organization and with alliance partners
Joule Clinical (formerly Syneos Health Clinical Staffing)Joule, a SystemOne division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.