Senior Manager, Technical Clinical Data Management

🕒 Outubro 29

🍂 Massachusetts – Remoto

🍂 Massachusetts – Remote

💵 $164.000 - $200.000 / ano

⏰ Tempo Integral

🟠 Sênior

👔 Gerente

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Deciphera Pharmaceuticals

SiteLinkedInTodas as Vagas

201 - 500 funcionários

Fundada em 2016

🏥 Saúde

🏭 Manufatura

🧬 Biotecnologia

Healthcare • Manufacturing • Biotechnology

A Deciphera Pharmaceuticals é uma empresa de biotecnologia dedicada a combater o câncer, desenvolvendo inibidores de quinase inovadores para melhorar os resultados dos pacientes. A empresa se concentra em projetar inibidores de quinase de controle de chave para abordar os mecanismos de resistência tumoral e farmacológica, com o objetivo de aprimorar as respostas ao tratamento para pacientes com câncer. A Deciphera possui um portfólio diversificado de candidatos a medicamentos, incluindo ripretinibe e vimseltinibe, e está comprometida em causar um impacto significativo na vida dos pacientes com câncer. A partir de junho de 2024, a Deciphera é uma subsidiária integral da ONO Pharma e continua a trabalhar para melhorar a saúde humana por meio de suas inovações científicas e abordagem centrada no paciente.

Descrição

• Take full accountability for end-to-end data management lifecycle activities across assigned clinical trials • Serve as the primary Data Management Study Lead • Manage timelines, cross-functional communication, risks, and deliverables • Represent Data Management on the Clinical Study Team • Lead study communications and manage expectations with the Data Management CRO • Oversee activities defined in the Data Management Plan and ensure deliverables meet quality and timeline expectations • Apply data intelligence to identify trends, strengthen performance monitoring, and improve operational efficiency • Partner with IT to streamline external data transfers and integrate data across systems • Oversee outsourced clinical data management vendors and ensure performance aligns with Deciphera standards • Review vendor invoices as applicable • Collaborate with cross-functional teams on data deliverables • Enhance clinical data management processes and strengthen cross-functional collaboration • Support department initiatives as needed • Lead clinical data management inspection activities and manage findings to resolution • Ensure clinical data management documentation is complete and filed in the Trial Master File • Perform other duties and responsibilities as assigned

🎯 Requisitos

• Bachelor's or master's degree with 8+ years of experience in Clinical Data Management • Knowledge of FDA/CFR and ICH/GCP • Familiarity with CDISC and CDASH standards • Experience with data visualization tools to build study-status and data quality dashboards • Experience creating and applying tools to clinical data workflows, including data review, automation, and visualization with appropriate validation and human oversight • Familiarity with AI (e.g. Copilot, Claude) • Effective communication, organizational, and project management skills • Experience building in Medidata RAVE • Hands-on experience using SAS for data extraction and validation • Experience with J-Review

🏖️ Benefícios

• Competitive salary and annual bonus • Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more • Generous parental leave and family planning benefits • Outstanding culture and opportunities for personal and professional growth • Long-term incentive plan • Other incentive compensation plans (if applicable)

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