Regulatory Data Technical Advisor

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🕒 vor 21 Tagen

🏛️ District of Columbia, Washington – Remote

🏛️ District of Columbia – Remote ☕ Washington – Remote

⏰ Vollzeit

🟠 Senior

🔴 Experte

🚔 Compliance

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BryceTech

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51 - 200 Mitarbeiter

Gegründet 2003

🏛️ Regierung

🚀 Luft- und Raumfahrt

Government • Defense • Aerospace

BryceTech ist ein Analyse- und Ingenieurbüro, das mit Kunden aus den Bereichen Wissenschaft und Technologie zusammenarbeitet, um Unterstützung bei Regierungsprogrammen und Unternehmensberatung zu bieten. Das Unternehmen offeriert eine Reihe von Dienstleistungen, darunter Systemtechnik, Datenanalyse, Programmmanagement, Technologiemanagement und Cybersicherheit. BryceTech ist besonders bekannt für seine Expertise in der Weltraumwirtschaft, im Bereich nationale Sicherheit, Verteidigung und im öffentlichen Gesundheitssektor. Das Unternehmen berät zudem bei Investitionen in Forschung und Entwicklung und unterstützt den Technologietransfer. BryceTech bedient sowohl staatliche als auch kommerzielle Kunden, indem es proprietäre, forschungsbasierte Modelle nutzt, um strategische Einblicke und wettbewerbsrelevante Informationen zu liefern.

Beschreibung

• Serve as technical SME for CDISC SEND and SENDIG-AR (2019) • Develop validation criteria, business rules, and quality control procedures for DCC ingestion of SEND datasets • Support design and implementation of DCC data architecture and metadata governance frameworks • Establish data acceptance and rejection criteria aligned with regulatory expectations • Contribute to DCC end user interface testing and acceptance criteria • Assist in developing end user training and implementation plans • Ensure alignment with Animal Rule regulatory requirements (21 CFR 314.600 and 601.90) • Assist other contractors by translating regulatory requirements into operational data standards specifications • Perform quality control of dataset packages • Integrate knowledge of nonclinical study conduct to assure correct dataset output • Knowledgably interact with study personnel as needed to prepare, review and troubleshoot issues for dataset packages • Communicate findings to team members and management • Obtain proficiency with DNCD quality control workflows to include regulatory dataset [e.g. SEND] review, study report QC, and other reviews, as required • Adhere to and/or assist in establishment/refinement of DNCD SOPs and business practice documents related to QC efforts • Learn data audit practices with possibility to assist in remote and/or on-site data audits of BARDA contracted research • Provide technical expertise to individual advanced research and development (ARD) and/or nonclinical project coordination teams (PCTs) • Act as the primary data management contact for BARDA ARD/nonclinical PCTs supporting contracts issued to CHEM, RADNUC, and BIOLOGICAL network contract research laboratories (CROs) • Coordinate with PCTs to determine intended use for data derived from contract(s) and establish data management plans intended to ensure data are fit for purpose • Coordinate with PCTs to ensure data management plans are included within contract management plans and quality assurance project plans established by CRO contractors • Develop strong PCT relationships that are driven by consistent study data analytic and management services in terms of quality and timeliness • Advise CRO contractors on data delivery and format requirements • Receive and review raw data from CRO contractors for completeness and quality according to established quality control standards • Coordinate with BARDA statisticians for appropriate methods and practices related to analytical support to PCTs

🎯 Anforderungen

• Advanced degree (e.g., Ph.D., M.P.H., M.S.) in biological and/or chemical sciences such as medicine, pharmacy, life science fields (e.g., immunology, molecular biology, biochemistry, microbiology, or similar) • Minimum eight (8) years of relevant industry and/or relevant postdoctoral experience in regulatory data standards and analytics • Direct SEND implementation experience • Client-focused approach to work; Ability to prioritize workload in a hybrid/remote work environment

🏖️ Vorteile

• competitive salary • comprehensive health plan including dental and vision coverage • company-paid life & disability insurance policies • 401(k) plan with company match • educational reimbursement program