Associate Director – External Data Acquisition Lead

🕒 Maio 22

🏖️ 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

Fundada em 1999

🧬 Biotecnologia

💰 $134.000.000 Post-IPO Equity em 2010-06

Biotechnology

Genmab é uma empresa de biotecnologia focada em transformar vidas por meio da ciência pioneira de anticorpos. A empresa é dedicada ao desenvolvimento de terapias inovadoras com anticorpos para diversas doenças, com o objetivo de melhorar os resultados dos pacientes e as opções de tratamento. Os esforços da Genmab em pesquisa e desenvolvimento de anticorpos destacam seu compromisso em avançar na ciência médica.

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 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