Senior Decentralized Clinical Care SME | Healthcare and Life Sciences [HHS115020]

Senior Decentralized Clinical Care SME | Healthcare and Life Sciences

ProSidian is a Management and Operations Consulting Services Firm focusing on providing value to clients through tailored solutions based on industry leading practices. ProSidian services focus on the broad spectrum of Risk Management, Compliance, Business Process, IT Effectiveness, Energy & Sustainability, and Talent Management. We help forward thinking clients solve problems and improve operations. Launched by former Big 4 Management Consultants; our multidisciplinary teams bring together the talents of nearly 190 professionals globally to complete a wide variety of engagements for Private Companies, Fortune 1,000 Enterprises, and Government Agencies of all sizes. Our Services are deployed across the enterprise, target drivers of economic profit (growth, margin and efficiency), and are aligned at the intersections of assets, processes, policies and people delivering value. ProSidian clients represent a broad spectrum of industries to include but are not limited to Energy, Manufacturing, Chemical, Retail, Healthcare, Telecommunications, Hospitality, Pharmaceuticals, Banking & Financial Services, Transportation, Federal and State Government Agencies.

ProSidian Seeks a Senior Decentralized Clinical Care SME | Healthcare and Life Sciences - DPLH Est.: 1912 Hrs. ST | 0 Hrs. OT on a Exempt Full-Time Basis Mid Atlantic | ProSidian Labor Category - Senior Consultant Mid Level Professional aligned under services related to NAICS: 541611 - DPLH Est.: 1912 Hrs. ST | 0 Hrs. OT on a Exempt Full-Time Basis located CONUS - Washington DC Across The Mid Atlantic Region supporting Advanced Scientific Professional Staffing Support Services in the various areas of interest within the Medical Countermeasures field of Research and Development (R&D)/Analytical Research and Development (AR&D) of biotechnology and biopharmaceuticals supporting BARDA. These services are critical in support of BARDA's mission to conduct R&D and AR&D efforts to provide medical countermeasures that address the public health medical consequences of chemical, biological, radiological, and nuclear (CBRN) events, pandemic influenza, and emerging infectious diseases.

Seeking Senior Decentralized Clinical Care SME candidates with relevant Healthcare And Life Sciences Sector Experience (functional and technical area expertise also ideal) to support professional services engagement for Healthcare And Life Sciences Sector Clients such as HHS. This as a Full-Time ProSidian W-2 Healthcare and Life Sciences Functional Area - Healthcare And Life Sciences Supply/Service Initiative and an employed position with commensurate benefits and competitive salary.

JOB OVERVIEW

Provide services and support as a Healthcare And Life Sciences (Senior Decentralized Clinical Care SME) in the Healthcare And Life Sciences Industry Sector focusing on Human Capital Solutions for clients such as Department of Health and Human Services (HHS - ASPR | BARDA) | HHS Administration for Strategic Preparedness and Response (ASPR) Center for Biomedical Advanced Research and Development Authority (BARDA) Generally Located In CONUS - Washington DC and across the Mid Atlantic Region (Of Country/World).

RESPONSIBILITIES AND DUTIES - Senior Decentralized Clinical Care SME | Healthcare and Life Sciences [HHS115020]

• Support BARDA Program Office(s) as a subject matter expert in the fields of Chemical Threats, Radiological/Nuclear Threats, Burn and Blast Injuries, or Biological Threats (including viral and bacterial threats), Influenza and Emerging Infectious Diseases Division (IEIDD) as well as the research, development, manufacture, and regulatory approval/ licensure/ clearance of medical countermeasures against these threats including but not limited to diagnostics and other medical devices/infrastructure vaccines and other preventives, and therapeutics.
• Candidates with experience in the following areas are desired: medicinal chemistry; preclinical development (animal models, pharmacology, toxicology); advanced clinical development (medical officers immunologists, clinical operations); analytical product testing and testing development; quality control; clinical and/or regulatory policy; and/or manufacturing (chemistry, manufacturing, and controls); process development, process scale-up and process optimization; device development and manufacturing, reliability engineering, Software, Assay chemistry, microbiology, virology, immunology. Plastic consumable design and manufacturing. Experience in manufacturing scalability and capacity expansion and sterile/aseptic technic, sterile manufacturing/filling and sterile facilities (sterile gowning) Provide guidance and recommendations on key issues related to the area(s) identified above.
• Serve as advisor(s) on Technical Evaluation Panels (TEPs) to include white papers/market research abstracts, technical proposals, and budget proposals.
• Participate as subject matter experts on Program Coordination Teams (PCTs)
• Provide expert assessments, recommendations, and guidance as well as educational material to PCT and COR as needed
• Provide subject matter expertise and advisory support to federal staff for development of cost estimates for notional programs/proposed work
• Review and comment on study protocols, study reports, regulatory documents, presentations, proposals, and related documents.
• Develop work products (including but not limited to expert summary reports, expert opinion assessment reports, analysis reports, manuscript writing/contribution, and review and technical assessments on a wide variety of documents related to BARDA's mission, including solicitations, white papers, proposals, and post-award contract documents and deliverables), as requested in their SME area and at their required level of expertise.
• Advise federal staff on the appropriateness and the probability of success of Contractor proposed statements of work Make suggestions on ways to improve those statements of work.
• Experience distilling complex information into informative and concise summaries, including providing risk/benefit analyses and balanced recommendations.
• Participate and aid in strategic discussions, working with USG, in building new program areas in alignment with BARDA's mission space.
• Provide recommendations for project development level portfolio management and oversight as required.
• Provide recommendations or advise on development, implement, and consciously improve Total Life Cycle Cost (TLCC) efforts; Participate in Market Research efforts.
• 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

Desired Qualifications For Senior Decentralized Clinical Care SME | Healthcare and Life Sciences [HHS115020] (HHS115020) Candidates:

• At least 10 years of relevant experience in clinical trial design and execution.
• Specific expertise in decentralized clinical trials (DCTs), including product development, adoption, and implementation (e.g., pragmatic or Real-World Evidence (RWE) studies).
• Experience with decentralized clinical trial (DCT) capabilities and tools

Education / Experience Requirements / Qualifications

• Advanced degree (e.g., M.D., Ph.D., or equivalent) or relevant clinical research qualifications.
• Education or formal training in clinical research, public health, or related discipline preferred

Skills Required

• Expertise in decentralized clinical trials (DCTs) and innovative clinical trial designs (pragmatic, RWE, etc.).
• Ability to integrate new technologies, processes, and approaches into clinical studies.
• Knowledge of the CRO and DCT organization landscape.
• Understanding of critical capabilities for executing clinical studies (e.g., quality systems, data management systems, laboratory facilities).
• Experience with non-traditional clinical sites (retail pharmacies, urgent care centers, telemedicine, at-home services).

Competencies Required

• Ability to design, execute, and manage decentralized clinical trials and clinical care delivery in non-traditional healthcare settings.
• Strong understanding of both clinical/technical and business administration aspects of clinical studies.
• Excellent communication and strategic thinking skills to inform and provide expert recommendations to BARDA program managers.
• Ability to evaluate DCT proposals and provide actionable feedback.
• Leadership in DCT evaluation for BARDA products being evaluated in decentralized settings.

Ancillary Details Of The Roles

• Experience in working with non-traditional clinical sites and integrating these settings into decentralized clinical trials.
• Familiarity with critical systems required for