Associate Director – External Data Acquisition Lead

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

📋 Description

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

• Shape 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.

• Direct 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 guarantee that external data acquisition aligns with operational and scientific goals.

• Create and manage Trial Data Integrity Plans (TDIP) and establish data transfer specifications (DTS) requirements.

• Confirm that data collection requirements are in line with external vendor capabilities, ensuring that vendor data is compatible with the clinical database and meets SDTM requirements for effective data integration, analysis, and reporting.

• Ensure vendor data is submitted in standardized data formats.

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

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

• Mentor and support junior External Data Acquisition Leads by offering guidance on best practices, issue resolution, and professional development.

• Lead cross-functional initiatives such as the development of Standard Operating Procedures (SOPs), process enhancements, tools optimization, and governance of external data standards.

• Collaborate with procurement, legal, and vendor management teams to review technical language in contracts and work orders, ensuring consistency with Genmab standards and systems.

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

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

• Ensure that external vendor deliverables comply with protocols, ICH, GCP, and SOPs.

⛳️ Requirements

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

• Over 10 years of experience in external or clinical data management, with a solid background in third-party vendor oversight and data acquisition.

• Proven experience 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 managing projects, vendors, and process improvements in global settings.

• Demonstrated success in prior 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