Senior Clinical Operations SME | Healthcare and Life SciencesProSidian 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.ProSidian Seeks a Senior Clinical Operations SME | Healthcare and Life Sciences - 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 Clinical Operations 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 Clinical Operations 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 Clinical Operations SME | Healthcare and Life Sciences (HHS ) 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 neededProvide subject matter expertise and advisory support to federal staff for development of cost estimates for notional programs/proposed workReview 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.QualificationsDesired Qualifications For Senior Clinical Operations SME | Healthcare and Life Sciences (HHS ) (HHS ) Candidates:At least 10 years of clinical trial operations experience beyond an advanced degree.Experience in registrational Phase II/III trials with DV25 graduated responsibilities, including executive-level positions.
Education / Experience Requirements / Qualifications Advanced degree in medicine, nursing, pharmacy, biotechnology, or a related field.
Skills Required Expertise in clinical trial operations, including observational and Phase I-IV trials (Clinical SME).Expertise in registrational Phase II/III trials (Senior SME).Ability to manage timelines, budgets, and deliverables with minimal oversight.Experience in developing, authoring, and reviewing Request for Task Orders (RTORs) and evaluating Clinical Research Organization (CRO) proposals.Familiarity with FDA regulatory submission processes, guidelines, and document reviews. Competencies Required Strong project management and clinical team leadership skills.Proficient in risk assessment and mitigation strategies (Senior SME).Strong analytical skills to monitor, assess, and course-correct contractors and vendors. Ancillary Details Of The Roles Deliverables include oversight and review of clinical studies, regulatory submissions, and study-specific documents (e.g., invoices).Development of independent cost, resource, and timeline estimates when required (Senior SME)Prepare and manage project timelines and budgets to ensure regulatory compliance and high-quality output. Other Details Senior SME candidates are expected to demonstrate significant leadership experience in clinical operations, including roles with executive responsibilities.Familiarity with BARDA products and advanced development contracts in vaccines, therapeutics, diagnostics, and devices is a plus.Additional Information CORE COMPETENCIES Teamwork – ability to foster teamwork collaboratively as a participant, and effectively as a team leader Leadership – ability to guide and lead colleagues on projects and initiatives Business Acumen – understanding and insight into how organizations perform, including business processes, data, systems, and people Communication – ability to effectively communicate to stakeholders of all levels orally and in writing Motivation – persistent in pursuit of quality and optimal client and company solutions Agility – ability to quickly understand and transition between different projects, concepts, initiatives, or work streams Judgment – exercises prudence and insight in decision-making process while mindful of other stakeholders and long-term ramifications Organization – ability to manage projects and activity, and prioritize tasks------------ ------------ ------------ OTHER REQUIREMENTS Business Tools – understanding and proficiency with business tools and technology, including Microsoft Office. The ideal candidate is advanced with Excel, Access, Outlook, PowerPoint and Word, and proficient with Adobe Acrobat, data analytic tools, and Visio with the ability to quickly learn other tools as necessary. Commitment - to work with smart
Senior Clinical Operations SME | Healthcare and Life Sciences [HHS113018] in washington at Unknown Company
This position is listed as contract and onsite.