Talent.com
Senior Manager, External Data Acquisition, Clinical Data Management
Senior Manager, External Data Acquisition, Clinical Data ManagementGenmab • Princeton, NJ, US
Senior Manager, External Data Acquisition, Clinical Data Management

Senior Manager, External Data Acquisition, Clinical Data Management

Genmab • Princeton, NJ, US
12 hours ago
Job type
  • Full-time
Job description

Senior Manager In External Data Acquisition

At Genmab, we are dedicated to building extraordinary futures, together, by developing antibody products and groundbreaking, knock-your-socks-off 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 include :

  • 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) for 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 GCPs, SOPs, regulatory requirements, and good data management practices.
  • Proficiency in CDISC (SDTM) standards and clinical data standards development.
  • Proven project management skills.
  • The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location.

    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
  • 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!

    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.

    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.

    Create a job alert for this search

    Clinical Data Manager • Princeton, NJ, US

    Related jobs
    CRNA

    CRNA

    Deborah Heart and Lung Center • Browns Mills, NJ, US
    Part-time
    Position Summary : .Responsible for preoperative assessment of patient status and ordering of preoperative medication under supervision with administration of drugs to p...Show more
    Last updated: 30+ days ago • Promoted
    RN - Case Manager

    RN - Case Manager

    Deborah Heart and Lung Center • Browns Mills, NJ, US
    Full-time
    Accountable for coordinating care across the continuum for an identified group of patients.Participate in the development of appropriate plans of care in conjunction with the physicians and other m...Show more
    Last updated: 17 days ago • Promoted
    Senior Manager, R&D Strategic Sourcing, Clinical Execution

    Senior Manager, R&D Strategic Sourcing, Clinical Execution

    New Jersey Staffing • Princeton, NJ, US
    Full-time
    Senior Manager, R&D Strategic Sourcing Clinical Execution.The Senior Manager, R&D Strategic Sourcing Clinical Execution is part of a global team which collaborates with R&D category leaders and bus...Show more
    Last updated: 12 hours ago • Promoted • New!
    Senior Manager - Cardiometabolic Sales Strategy and Engagement

    Senior Manager - Cardiometabolic Sales Strategy and Engagement

    NY Staffing • Plainsboro, NJ, US
    Full-time
    Senior Manager Cm Sales Strategy And Engagement.The Cardiometabolic Care Sales Team is at the forefront of US sales efforts for Novo Nordisk's robust cardiometabolic product portfolio.Our ambition ...Show more
    Last updated: 6 days ago • Promoted
    RN - Assist Adv Heart Failure Program VAD Coordinator (Clinical Cardiology)

    RN - Assist Adv Heart Failure Program VAD Coordinator (Clinical Cardiology)

    Deborah Heart and Lung Center • BROWNS MILLS, NJ, US
    Full-time
    Assistant Advanced Heart Failure Program VAD Coordinator will function as a central figure in the overall operations of the Advanced Heart Failure Program including CHF, LVAD, and other related pro...Show more
    Last updated: 24 days ago • Promoted
    Cardiology Business Manager

    Cardiology Business Manager

    Deborah Heart and Lung Center • BROWNS MILLS, NJ, US
    Full-time
    The Cardiology Business Manager is responsible for the daily business, data, and financial operations of the cardiology product line. This manager-level leader partners with clinical and administrat...Show more
    Last updated: 7 days ago • Promoted
    Rare Disease Account Manager, Hematology (Miami, FL)

    Rare Disease Account Manager, Hematology (Miami, FL)

    Recordati Industria Chimica e Farmaceutica S.p.A • Bridgewater, NJ, United States
    Full-time
    This position is with Recordati Rare Diseases, Inc.RRD), North America, an affiliate of Recordati.RRD) develops high-impact therapies for rare diseases, focusing on providing treatments to underser...Show more
    Last updated: 11 days ago • Promoted
    RN - Case Manager (Care Coordination)

    RN - Case Manager (Care Coordination)

    Deborah Heart and Lung Center • Browns Mills, NJ, US
    Full-time
    Accountable for coordinating care across the continuum for an identified group of patients.Participate in the development of appropriate plans of care in conjunction with the physicians and other m...Show more
    Last updated: 30+ days ago • Promoted
    Travel Physical Therapy Assistant - $1,333 per week

    Travel Physical Therapy Assistant - $1,333 per week

    TNAA TotalMed Allied • Levittown, PA, United States
    Full-time
    TNAA TotalMed Allied is seeking a travel Physical Therapy Assistant for a travel job in Levittown, Pennsylvania.Job Description & Requirements. Additional certifications may be required before begin...Show more
    Last updated: 17 days ago • Promoted
    Senior Patient Safety Data Acquisition and Support Manager

    Senior Patient Safety Data Acquisition and Support Manager

    Novo Nordisk A / S • Plainsboro Township, NJ, United States
    Temporary
    Senior Patient Safety Data Acquisition and Support Manager.Reg Affairs & Safety Pharmacovigilance.The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse an...Show more
    Last updated: 13 hours ago • Promoted • New!
    Senior Medical Director - Psychiatrist - Remote Based

    Senior Medical Director - Psychiatrist - Remote Based

    Syneos Health / inVentiv Health Commercial LLC • Bridgewater, NJ, United States
    Remote
    Full-time
    Senior Medical Director - Psychiatrist - Remote Based.Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.We translate unique c...Show more
    Last updated: 30+ days ago • Promoted
    Senior Manager, Clinical Quality Oversight Monitor

    Senior Manager, Clinical Quality Oversight Monitor

    Kyowa Kirin • Princeton, NJ, US
    Full-time
    Accelerate Your Career With Kyowa Kirin North America.Be a part of Kyowa Kirin's growth story.Explore opportunities to join our team and see our open roles. Kyowa Kirin is a global specialty pharmac...Show more
    Last updated: 30+ days ago • Promoted
    Director Enterprise Data & Analytics

    Director Enterprise Data & Analytics

    Capital Health • Hopewell, NJ, US
    Full-time +1
    Director Of Enterprise Data & Analytics.Capital Health is the region's leader in providing progressive, quality patient care with significant investments in our exceptional physicians, nurses and s...Show more
    Last updated: 30+ days ago • Promoted
    Senior Manager, Patient Services and Distribution Effectiveness

    Senior Manager, Patient Services and Distribution Effectiveness

    New Jersey Staffing • Princeton, NJ, US
    Full-time
    Senior Manager, Patient Services And Distribution Effectiveness.Acadia is committed to turning scientific promise into meaningful innovation that makes the difference for underserved neurological a...Show more
    Last updated: 12 hours ago • Promoted • New!
    Senior Manager, Market Access Analytics & Insights

    Senior Manager, Market Access Analytics & Insights

    Pharming Healthcare Inc • Warren, NJ, United States
    Full-time
    We are developing and commercializing a portfolio of innovative medicines, including small molecules and biologics.Pharming is headquartered in Leiden, the Netherlands, with a significant proportio...Show more
    Last updated: 30+ days ago • Promoted
    Senior Clinical Data Manager

    Senior Clinical Data Manager

    Genmab • Princeton, NJ, US
    Full-time
    At Genmab, we are dedicated to building extraordinary futures, together, by developing antibody products and groundbreaking, knock-your-socks-off antibody medicines that change lives and the future...Show more
    Last updated: 30+ days ago • Promoted
    APN - Electrophysiology (Full Time)

    APN - Electrophysiology (Full Time)

    Deborah Heart and Lung Center • BROWNS MILLS, NJ, US
    Full-time
    In Collaboration with the Attending Physicians, the Nurse Practitioner / Physician Assistant will assess, diagnose, treat, and manage patients in the Electrophysiology Outpatient and Inpatient areas....Show more
    Last updated: 24 days ago • Promoted
    Senior Patient Safety and GxP Document Oversight Manager

    Senior Patient Safety and GxP Document Oversight Manager

    Novo Nordisk • Plainsboro, NJ, US
    Full-time
    Senior Patient Safety and GxP Document Oversight Manager.Facility : Reg Affairs & Safety Pharmacovigilance.The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most di...Show more
    Last updated: 30+ days ago • Promoted