Associate Director - External Data Acquisition Lead (EDAL)

Genmab; Utrecht; Hybrid; EUR 134.335 - 201.502; Vollzeit

Benefits dieser Stelle

401(k) Plan: 100% match on contributions

Health Benefits: Two medical plan options

Paid vacation, sick leave, and parental leave

Tuition reimbursement

Zusammenfassung

Genmab is seeking an Associate Director, External Data Acquisition Lead. This role focuses on the management of clinical data and oversight of external data integration processes. Key responsibilities include leading data acquisition efforts, collaborating with cross-functional teams, and ensuring compliance with standards.

The ideal candidate will have a strong background in external data management, vendor oversight, and experience in complex data flows.

Qualifikationen

• 10+ years of experience in external or clinical data management.
• Strong third-party vendor oversight and data acquisition experience.
• Experience designing and governing data transfer specifications.

Aufgaben

• Lead external data acquisition across studies and programs.
• Influence protocol development related to external data.
• Partner with stakeholders to achieve operational and scientific goals.

Kenntnisse

External data management

Vendor oversight

Data acquisition

Project management

Clinical operations

Ausbildung

Bachelor’s or Master’s degree in relevant technical area

Jobbeschreibung

Role

The Associate Director, External Data Acquisition Lead (EDAL) role is a clinical data manager with expertise in the data collection of third‑party data from various external providers (labs, eCOA providers, technology providers, etc.). The EDAL provides a leadership role in the oversight of external clinical data integration processes and data quality from various external providers performing testing or data collection services on behalf of Genmab. The EDAL serves as the subject matter expert for all external data management activities performed for clinical trial teams. This role provides strategic data management expertise and is accountable for all end‑to‑end data management activities and deliverables pertaining to external data. The employee will provide oversight of external vendors and the data and/or data services they provide to Genmab. The External Data Lead will support the development and optimization of processes and tools to enable success of the Clinical Operations department. The employee will represent Data Management in operational committees with partners and/or data‑management/statistical vendors. The employee will support and train colleagues on handling external data management processes, and may act as a mentor. The employee will also support the overall strategy and development of data management by attending/leading task‑force initiatives within the department and/or in cross‑departmental teams.

Responsibilities

• 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 that 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.

Salary

For US based candidates, the proposed salary band for this position is $157,360.00—$236,040.00. The actual salary offer will consider a wide range of factors, including skills, qualifications, experience, and location. Certain positions are eligible for discretionary bonuses and long‑term incentives.

Benefits

When you join Genmab, you’re joining a culture that supports your physical, financial, social, and emotional wellness. Within the first year, regular full‑time US employees are eligible for the following 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

Location

Genmab maximizes the efficiency of an agile working environment, when possible, for the betterment of employee work‑life balance. Our offices are crafted as open, community‑based spaces that work to connect employees while being immersed in our powerful laboratories. Whether you’re in one of our office spaces or working remotely, we thrive on connecting with each other to innovate.