Genmab
Senior Manager, External Data Acquisition, Clinical Data Management
Genmab, Princeton, New Jersey, us, 08543
Senior Manager, External Data Acquisition, Clinical Data Management
At Genmab, we are dedicated to building extraordinary futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines® that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals’ unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees. Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so.
Does this inspire you and feel like a fit? Then we would love to have you join us!
The Role As a Senior Manager in External Data Acquisition, you will play a pivotal role within our Clinical Data Management team. Your primary responsibility will be to oversee the acquisition and integration of third‑party data (e.g., laboratories, eCOA providers, technology providers, etc.) who perform testing or data collection services on behalf of Genmab, ensuring its alignment with clinical trials’ objectives and regulatory standards.
Responsibilities
Lead and provide strategic insights into protocol development, specifically focusing on external data collection and integration.
Standardize data type specifications to align with Electronic Data Capture (EDC) requirements and clinical trial objectives.
Ensure that data transfer processes comply with CDASH and SDTM standards, facilitating efficient data analysis and reporting.
Develop detailed data transfer specifications for acquiring external data from third‑party vendors.
Coordinate with vendors to guarantee that data collection is compatible with clinical databases and meets SDTM requirements.
Oversee Data Management Contract Research Organizations (DM CROs) to enable seamless external data transfers.
Review and assess vendor contracts, setup specifications, and test data transfers.
Proactively identify and resolve issues related to external data transfers throughout the trial lifecycle.
Collaborate with internal teams (Biomarker Operations, Data Management, Data Analytics, Medical, Statistics, etc.) and external partners to ensure adherence to Genmab’s requirements and timelines.
Requirements
Bachelor’s degree in science or a related field.
5–8+ years of experience in clinical data management with a focus on external data in the biotech/pharma industry.
Profound knowledge of oncology trials, EDC systems, and technical aspects of data transfer.
Strong understanding of data management processes, tools, methodologies, and documentation.
Familiarity with GCP, SOPs, regulatory requirements, and good data‑management practices.
Proficiency in CDISC (SDTM) standards and clinical data standards development.
Proven project‑management skills.
About You
Passionate about Genmab’s mission and driven to make a significant impact in a dynamic biotech environment.
Exceptional technical expertise in clinical data management and external data acquisition.
Ability to thrive in a fast‑paced setting, maintaining the quality and integrity of clinical data.
Salary (US) Proposed salary band: $124,320.00 – $186,480.00. The actual offer will consider skills, qualifications, experience, location, and may include 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.
Paid time off: vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave.
Support resources: 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.
Locations Genmab maximizes the efficiency of an agile working environment, encouraging work‑life balance. Our offices are open, community‑based spaces that foster collaboration. Whether in one of our offices or working remotely, we thrive on connecting with each other to innovate.
About Genmab Genmab is an international biotechnology company focused on improving patient lives through innovative antibody therapeutics. For 25 years, its team has invented next‑generation antibody technology platforms and harnessed translational, quantitative and data sciences. Our proprietary pipeline includes bispecific T‑cell engagers, antibody‑drug conjugates, next‑generation immune checkpoint modulators and effector‑function‑enhanced antibodies. By 2030, we aim to transform lives with Knock‑Your‑Socks‑Off (KYSO®) antibody medicines.
Established in 1999 and headquartered in Copenhagen, Denmark, Genmab has an international presence across North America, Europe and Asia Pacific. For more information, 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.
#J-18808-Ljbffr
Does this inspire you and feel like a fit? Then we would love to have you join us!
The Role As a Senior Manager in External Data Acquisition, you will play a pivotal role within our Clinical Data Management team. Your primary responsibility will be to oversee the acquisition and integration of third‑party data (e.g., laboratories, eCOA providers, technology providers, etc.) who perform testing or data collection services on behalf of Genmab, ensuring its alignment with clinical trials’ objectives and regulatory standards.
Responsibilities
Lead and provide strategic insights into protocol development, specifically focusing on external data collection and integration.
Standardize data type specifications to align with Electronic Data Capture (EDC) requirements and clinical trial objectives.
Ensure that data transfer processes comply with CDASH and SDTM standards, facilitating efficient data analysis and reporting.
Develop detailed data transfer specifications for acquiring external data from third‑party vendors.
Coordinate with vendors to guarantee that data collection is compatible with clinical databases and meets SDTM requirements.
Oversee Data Management Contract Research Organizations (DM CROs) to enable seamless external data transfers.
Review and assess vendor contracts, setup specifications, and test data transfers.
Proactively identify and resolve issues related to external data transfers throughout the trial lifecycle.
Collaborate with internal teams (Biomarker Operations, Data Management, Data Analytics, Medical, Statistics, etc.) and external partners to ensure adherence to Genmab’s requirements and timelines.
Requirements
Bachelor’s degree in science or a related field.
5–8+ years of experience in clinical data management with a focus on external data in the biotech/pharma industry.
Profound knowledge of oncology trials, EDC systems, and technical aspects of data transfer.
Strong understanding of data management processes, tools, methodologies, and documentation.
Familiarity with GCP, SOPs, regulatory requirements, and good data‑management practices.
Proficiency in CDISC (SDTM) standards and clinical data standards development.
Proven project‑management skills.
About You
Passionate about Genmab’s mission and driven to make a significant impact in a dynamic biotech environment.
Exceptional technical expertise in clinical data management and external data acquisition.
Ability to thrive in a fast‑paced setting, maintaining the quality and integrity of clinical data.
Salary (US) Proposed salary band: $124,320.00 – $186,480.00. The actual offer will consider skills, qualifications, experience, location, and may include 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.
Paid time off: vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave.
Support resources: 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.
Locations Genmab maximizes the efficiency of an agile working environment, encouraging work‑life balance. Our offices are open, community‑based spaces that foster collaboration. Whether in one of our offices or working remotely, we thrive on connecting with each other to innovate.
About Genmab Genmab is an international biotechnology company focused on improving patient lives through innovative antibody therapeutics. For 25 years, its team has invented next‑generation antibody technology platforms and harnessed translational, quantitative and data sciences. Our proprietary pipeline includes bispecific T‑cell engagers, antibody‑drug conjugates, next‑generation immune checkpoint modulators and effector‑function‑enhanced antibodies. By 2030, we aim to transform lives with Knock‑Your‑Socks‑Off (KYSO®) antibody medicines.
Established in 1999 and headquartered in Copenhagen, Denmark, Genmab has an international presence across North America, Europe and Asia Pacific. For more information, 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.
#J-18808-Ljbffr