What are the responsibilities and job description for the BARDA Senior Decentralized Clinical Care SME position at BryceTech?
Company Description
BryceTech has partnered with technology and R&D clients to deliver mission and business success since 2017. Bryce combines core competencies in analytics and engineering with domain expertise. Our teams help government agencies, Fortune 500 firms, and investors manage complex programs, develop IT tools, and forecast critical outcomes. We offer clients proprietary, research-based models that enable evidence-based decision-making. Bryce cultivates a culture of engagement and partnership with our clients. BryceTech is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Job Description
Background
In 2006 the Biomedical Advanced Research and Development Authority (BARDA) was established to support and advance the development of vaccines, therapeutics, diagnostics, and innovative technologies for use during public health emergencies. The BARDA model’s success is codified in 1) 60 Food and Drug Administration (FDA) approvals, licenses, and clearances, 2) 101 Biomedical products supported for COVID-19 response, and 3) 136 BARDA-supported COVID-19 partnerships. This success centers on BARDA’s public-private partnerships, which have accelerated the development of Medical Counter Measures (MCM) vital to our National Security. BARDA provides its partners critical capability and technical support needed to accelerate MCM regulatory approval and deployment, including support for advanced research and development (AR&D), FDA licensure, and clinical use.
Job Responsibilities
- Support BARDA program managers as advisor on decentralized clinical trials (DCTs).
- Participate in BARDA program teams to support evaluation of BARDA products that are being evaluated in decentralized clinical settings or with decentralized capabilities and tools.
- Review and provide expert opinion and recommendation on proposals that include decentralized clinical trial capabilities and provide feedback to Government program Managers.
- Serve as a subject matter expert (SME) in the design, execution and management of decentralized clinical trials research and clinical care delivery in non-traditional site-based healthcare settings for BARDA funded efforts
- Inform on landscape of organizations conducting DCTs and provide insight as to both challenges and strategic value of DCTs.
Qualifications
At least ten (10) years of relevant experience. Individual should possess specific expertise in diverse clinical study designs, including clinical studies that support product development as well as product adoption and implementation (e.g., pragmatic or RWE studies) and decentralized approaches.
Individual should have expertise around clinical trial innovation and knowledge around what would be needed to integrate new processes, technologies, and approaches into clinical studies.
- Individual should have good understanding of CRO and DCT organization landscape.
- Knowledge of critical capabilities to execute clinical studies such as necessary quality systems, data management systems, laboratory facilities, etc.
- Ideally individual would have experience inworking in non-traditional clinical sites, such as retail pharmacies and clinics, urgent care centers, or telemedicine/at-home services.
- Knowledge of both the clinical/technical aspects of executing clinical studies as well as the business administration and drivers for successful execution of clinical studies would be desired.
- The SME's experience should ideally include supporting diverse DCT, pragmatic and RWE approaches in clinical trials and products under evaluation (e.g., vaccines, therapeutics, diagnostics/devices).
Additional Information
This is remote position.
BryceTech offers a full range of benefits, including competitive salary, a comprehensive health plan including dental and vision coverage, company-paid life & disability insurance policies, 401(k) plan with company match, and an educational reimbursement program.
All your information will be kept confidential according to EEO guidelines.
