Senior Decentralized Clinical Care SME
BryceTech
๐Remote - United States
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Summary
Join BryceTech as a subject matter expert (SME) advising BARDA program managers on decentralized clinical trials (DCTs). You will participate in program teams evaluating BARDA products in decentralized settings, review proposals, and provide expert recommendations. Your expertise in DCT design, execution, and management in non-traditional healthcare settings is crucial. You will also inform on the DCT landscape and its challenges and strategic value. This is a remote position offering a competitive salary and a comprehensive benefits package.
Requirements
- At least ten (10) years of relevant experience
- 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
- Have expertise around clinical trial innovation and knowledge around what would be needed to integrate new processes, technologies, and approaches into clinical studies
- 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
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
Preferred Qualifications
- Experience in working 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
- Experience supporting diverse DCT, pragmatic and RWE approaches in clinical trials and products under evaluation (e.g., vaccines, therapeutics, diagnostics/devices)
Benefits
- Competitive salary
- A comprehensive health plan including dental and vision coverage
- Company-paid life & disability insurance policies
- 401(k) plan with company match
- An educational reimbursement program
- Remote position
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