Associate Director – External Data Acquisition Lead

Role Overview

• 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.

Requirements

• 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.

Tech Stack

• Google Cloud Platform

Benefits

• 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