Associate Director - External Data Acquisition Lead (EDAL), Utrecht
Associate Director - External Data Acquisition Lead (EDAL), Utrecht
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Utrecht, Nederland
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Geplaatst op: gisteren
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Onthouden
Advertentietekst
Role Overview
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.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 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. 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 supportingEDC 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 (US‑based candidates)
$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.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. 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.
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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.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 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. 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 supportingEDC 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 (US‑based candidates)
$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.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. 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.
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Belangrijke informatie
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BedrijfsnaamGenmab A/S
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PositieAssociate Director - External Data Acquisition Lead (EDAL)
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