Associate Director, Data Management

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🕒 Fevereiro 19

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $166.000 - $188.000 / ano

⏰ Tempo Integral

🟠 Sênior

👔 Diretor

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Praxis

SiteLinkedInTodas as Vagas

11 - 50 funcionários

Fundada em 2002

🧬 Biotecnologia

⚕️ Seguro de Saúde

🔬 Ciência

Biotechnology • Healthcare Insurance • Science

A Praxis é uma empresa dedicada a conectar pacientes com oportunidades significativas de ensaios clínicos. Com foco na criação de programas de recrutamento personalizados, a Praxis utiliza uma variedade de ferramentas especializadas e vasta experiência em diversas áreas terapêuticas para garantir que alcancem os pacientes certos em todo o mundo. Estabelecida em 2002, a empresa enfatiza a importância do engajamento do paciente e utiliza insights sofisticados de dados para aprimorar a jornada do paciente na pesquisa clínica.

Descrição

• Directly contributes to the oversight of Data Management service providers and external vendors on assigned studies and programs, ensuring milestones and quality deliverables are achieved on time, within budget, and in accordance with regulatory requirements. • Serves as the point of contact for decision making and resolution within and across studies and programs. • Reviews and approves Data Management related documentation for quality, completeness, and accuracy; • Performs secondary User Acceptance Testing (UAT) of the EDC system prior to deployment to the production environment. • Contributes to and oversee the development of the Integrated Oversight Plan, establishing an internal cross-functional oversight plan to ensure data quality and demonstrate oversight; conducts DM data review per the plan using appropriate tools and systems. • Ensures the timely provisioning of feedback on draft protocols, risk assessments, and functional area plans and outputs as appropriate. • Participate in continual development through the acquisition and enhancement of knowledge related to drug development, clinical trials methodology, and DM best practices, and apply the information to make recommendations for improvement to processes and business performance.

🎯 Requisitos

• Bachelor’s degree required within a scientific discipline, pharmaceutical sciences, engineering, or related field. • Requires a minimum of 5 years of Clinical Data Management experience in a pharmaceutical or CRO setting; 7+ years preferred. • Significant experience in managing outsourced data management activities. • Thorough understanding of the drug development process, clinical trial methodology, regulatory requirements, and GCP. • Current and extensive knowledge of industry Data Management best practices and processes and understanding of Risk Based Quality Management (RBQM) principles. • Strong experience with computerized systems including EDC (preferably Medrio, Medidata RAVE), IRT, eCOA, and ePRO. • Experience with data visualization tools (e.g. Power BI, Spotfire) and advanced analytics systems (e.g. Medidata CSA, CluePoints) preferred. • CCDM is preferred. • Knowledge of SAS and database programming, systems integration experience and understanding of CDASH and CDISC standards are preferred.

🏖️ Benefícios

• 99% of the premium paid for medical, dental, and vision plans. • Company-paid life insurance. • AD&D and disability benefits. • Voluntary plans to personalize coverage. • 401(k) matching $1 for $1 up to 6% on eligible contributions. • Long-term stock incentives and ESPP. • Discretionary quarterly bonus. • Extremely flexible wellness benefit. • Generous PTO. • Paid holidays and company-wide shutdowns.