Associate Director – External Data Acquisition Lead

This is a fully remote position, open to applicants in New Jersey.

📋 Description

• Lead the acquisition of external data across multiple studies/programs, ensuring the delivery of high-quality, timely, and analysis-ready data that aligns with trial objectives.

• Influence the development of protocols and amendments by providing insights on the design of external data collection, integration feasibility, and compliance with CDASH/SDTM and EDC requirements.

• Oversee the planning and management of external data flow strategies and data transfer specifications (DTS) across various data types (PK/ADA, biomarker, imaging, central lab, eCOA/ePRO, PD, IRT, etc.) to ensure compliant integration.

• Collaborate with cross-functional stakeholders to ensure that external data acquisition aligns with both operational and scientific goals.

• Develop and oversee Trial Data Integrity Plans (TDIP) and Data Flow.

• Create and sustain data transfer specifications (DTS) requirements, ensuring that data collection standards are compatible with external vendor capabilities and that vendor data aligns with clinical database and SDTM requirements to facilitate data integration, analysis, and reporting. Ensure that vendor data is submitted in standard data formats.

• Conduct comprehensive reviews of external vendors' budgets and change orders.

• Serve as the escalation point for complex vendor issues such as timeline deviations, integration challenges, and misalignment with trial needs.

• Mentor and guide junior External Data Acquisition Leads, offering direction on best practices, issue resolution, and professional development.

• Lead cross-functional projects including SOP development, process enhancement, tools optimization, and governance of external data standards.

• Collaborate with procurement, legal, and vendor managers to review the technical language in contracts and work orders, ensuring compliance with Genmab standards and systems.

• Foster consistency and scalability at the portfolio level through training, knowledge sharing, and strategic planning assistance.

• Mentor and develop team members to ensure uniformity in External Data Management practices.

• Ensure that External Vendor deliverables comply with protocol, ICH, GCP, and SOPs.

⛳️ Requirements

• Bachelor’s or Master's degree in a relevant technical discipline; a Master’s degree is preferred.

• Over 10 years of experience in external or clinical data management, with robust oversight of third-party vendors and data acquisition experience.

• Experience working with Oncology trials and data.

• Proficient in designing and managing DTS and complex data flows that support EDC integration and adhere to CDISC standards (CDASH, SDTM).

• Strong understanding of various external data types (e.g., biomarker, central lab, imaging, eCOA/ePRO, genomic) and the ability to align acquisition strategies with clinical and analytical objectives.

• Experience in project management, vendor oversight, and process improvement within global environments.

• Demonstrated success in previous roles.

🏝️ 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.