Senior Manager, External Data Acquisition, Clinical Data Management

At Genmab, we are dedicated to building extra[not]ordinary® 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) 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.

• 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.

• 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.

• 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!