Associate Director – External Data Acquisition Lead

🕒 Julho 28

🏖️ New Jersey – Remoto

🏖️ New Jersey – Remote

💵 $157.360 - $236.040 / ano

⏰ Tempo Integral

🟠 Sênior

👔 Diretor

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Genmab

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

🧬 Biotecnologia

💊 Farmacêutico

🏥 Saúde

Biotechnology • Pharmaceuticals • Healthcare

A Genmab é uma empresa de biotecnologia focada em inovar na ciência dos anticorpos para transformar a vida dos pacientes. A empresa desenvolve anticorpos terapêuticos e tecnologias baseadas em anticorpos para o tratamento de câncer e outras doenças, com ênfase na engenharia inovadora de anticorpos e abordagens de imunoterapia. A Genmab faz parcerias com outras empresas biofarmacêuticas para avançar medicamentos baseados em anticorpos em estágio clínico e comercial.

Descrição

• Lead external data acquisition across one or more studies/programs, ensuring high-quality, timely, analysis-ready data aligned with trial objectives. • Influence protocol and amendment development by advising on external data collection design, integration feasibility, and alignment with CDASH/SDTM and EDC requirements. • Lead planning and oversight of external data flow strategies and DTS across diverse data types (PK/ADA, biomarker, imaging, central lab, eCOA/ePRO, PD, IRT, etc.) to ensure compliant integration. • Partner with cross-functional stakeholders to ensure external data acquisition supports operational and scientific goals. • Develop and manage Trial Data Integrity Plans (TDIP) and Data Flow. • Create and maintain data transfer specifications (DTS) requirements. Ensure data collection requirements are aligned with external vendor capabilities and vendor data are compatible with the clinical database and SDTM requirements to support data integration, analysis and reporting. Ensure vendor data is transferred in standard data formats. • Provide thorough review of external vendors budget and change order. • Act as escalation point for complex vendor issues (timeline deviations, integration challenges, misalignment to trial needs). • Mentor and guide junior External Data Acquisition Leads, providing direction on best practices, issue resolution, and development. • Lead cross-functional initiatives including SOP development, process improvement, tools optimization, and external data standards governance. • Partner with procurement/legal/vendor managers to review technical language in contracts and work orders, ensuring alignment with Genmab standards and systems. • Promote portfolio-level consistency and scalability through training, knowledge sharing, and strategic planning support. • Mentor and develop team members to ensure consistency of External Data Management practices. • Ensure External Vendor deliverables are performed in compliance with protocol, ICH, GCP and SOPs

🎯 Requisitos

• Bachelor’s or Master's degree in a relevant technical area; Master’s degree preferred. • 10+ years of experience in external or clinical data management, with strong third-party vendor oversight and data acquisition experience. • Experience working on Oncology trials/data • Experience designing and governing DTS and complex data flows supporting EDC integration and CDISC standards (CDASH, SDTM). • Strong knowledge of diverse external data types (e.g., biomarker, central lab, imaging, eCOA/ePRO, genomic) and ability to align acquisition strategies to clinical and analytical objectives. • Experience managing projects, vendors, and process improvements in global environments. • Proven performance in earlier role.

🏖️ Benefícios

• 401(k) Plan: 100% match on the first 6% of contributions • Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance • Voluntary Plans: Critical illness, accident, and hospital indemnity insurance • Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave • Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support • Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses