Regulatory Data Technical Advisor

Emploi pas sur LinkedIn

🕒 il y a 1 mois

🏛️ District of Columbia, Washington – Distant

🏛️ District of Columbia – Remote ☕ Washington – Remote

⏰ Temps Plein

🟠 Senior

🔴 Expert

🚔 Conformité

Postuler Maintenant

Trouver des Emplois à Distance Similaires

Recevoir des emails pour des emplois à distance

📊 Vérifiez votre score de CV pour ce poste

Améliorez vos chances d'obtenir un entretien en vérifiant votre score de CV avant de postuler.

Télécharger le CV

BryceTech

Site WebLinkedInTous les Emplois

51 - 200 employés

Fondée en 2003

🏛️ Gouvernement

🚀 Aérospatiale

Government • Defense • Aerospace

BryceTech est une entreprise d'analyse et d'ingénierie qui collabore avec des clients dans les domaines de la science et de la technologie, en fournissant un soutien aux programmes gouvernementaux et des services de conseil aux entreprises. La société offre une gamme de services, notamment en ingénierie des systèmes, analyse de données, gestion de programmes, gestion de portefeuilles technologiques et cybersécurité. BryceTech est particulièrement reconnue pour son expertise dans l'économie spatiale, la sécurité nationale, la défense et les secteurs de la santé publique. L'entreprise conseille également sur les investissements en recherche et développement et soutient le transfert technologique. BryceTech dessert à la fois les clients gouvernementaux et commerciaux, en utilisant des modèles exclusifs basés sur la recherche pour fournir des informations stratégiques et du renseignement concurrentiel.

Description

• 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

🎯 Exigences

• 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

🏖️ Avantages

• 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