Associate Director - External Data Acquisition Lead (EDAL)

Genmab; København; Ibrido; DKK 1.050.000 - 1.576.000; Tempo pieno

Vantaggi offerti da questo lavoro

401(k) Plan matching

Health benefits

Parental leave

Descrizione del lavoro

Genmab is seeking an Associate Director, External Data Acquisition Lead to oversee the collection and integration of third-party data for oncology programs. The role emphasizes leadership in external data management, vendor oversight, and ensuring SDTM/CDASH alignment across trials.

You will drive DTS design and data transfer specifications while mentoring junior leads and partnering with cross-functional teams to meet trial objectives and regulatory expectations.

Competenze

• 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 working on Oncology trials/data
• Experience designing and governing DTS and complex data flows supporting EDC integration and CDISC standards (CDASH, SDTM).
• Strong knowledge of diverse external data types (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.

Mansioni

• 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 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.
• 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

Conoscenze

External Data Management

Vendor Oversight

CDISC/CDASH/SDTM

Project Management

Leadership/Mentoring

Formazione

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

Strumenti

DTS

Descrizione del lavoro

The Role

The Associate Director, External Data Acquisition Lead (EDAL) role is a clinical data manager with expertise in the data collection of 3rd party data from various external providers (e.g. laboratories, eCOA providers, technology providers, etc.). The EDAL provides a leadership role in the oversight of the external clinical data integration processes as well as oversight of 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 Committee's/fora with the partners and/or DM/stat vendors. The employee will support /train colleagues in and advise on handling of external data management related processes/issues and may act as a mentor. Moreover, the employee shall support the overall strategy and development of Data Management by attending/leading task force initiatives within the department and/or as part of cross-departmental teams.

Responibilites

• 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 working on Oncology trials/data
• 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.

For US based candidates, the proposed salary band for this position is as follows:

$157,360.00---$236,040.00

The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives.

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 U.S. Employees Are Eligible For

• 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

About You

• You are genuinely passionate about our purpose
• You bring precision and excellence to all that you do
• You believe in our rooted-in-science approach to problem-solving
• You are a generous collaborator who can work in teams with a broad spectrum of backgrounds
• You take pride in enabling the best work of others on the team
• You can grapple with the unknown and be innovative
• You have experience working in a fast-growing, dynamic company (or a strong desire to)
• You work hard and are not afraid to have a little fun while you do so!

Locations

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.

About Genmab

Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab's vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO®) antibody medicines.

Established in 1999, Genmab is headquartered in Copenhagen, Denmark with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X.

Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice (genmab.com).

Please note that if you are applying for a position in the Netherlands, Genmab's policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.