At Genmab, we’re committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.

The Role
As a (Senior) Manager in External Data Quality Management, you will play a critical role within our Clinical Data Management team, primarily responsible for overseeing the quality and reconciliation of external data provided by third-party vendors, such as laboratories, eCOA providers, and technology vendors. Your expertise will be pivotal in integrating external data into clinical trial databases while ensuring the highest standards of data accuracy and consistency across all studies.

Responsibilities:

• Oversee and ensure the quality of data provided by external third-party providers.
• Coordinate with internal stakeholders and external partners to optimize data collection strategies to meet trial analysis, reporting, and research needs.
• Develop and execute study-specific data reconciliation plans in collaboration with Data Management (DM) and Clinical Research Organizations (CROs).
• Manage third-party vendors and central labs, including conducting performance reviews, resolving issues, and spearheading process improvement initiatives.
• Ensure timely and accurate delivery of external data, managing timelines and project deliverables effectively.
• Support process improvements and foster knowledge sharing within the data management teams.

Requirements:

• Bachelor’s degree in science or related field.
• Minimum of 5 years of experience in external data management, with extensive experience in third-party vendor management and data oversight.
• Experience in clinical data management within a clinical research environment, preferably including oncology trials.
• Proficiency in data reconciliation processes and a thorough understanding of various data types, testing methodologies, and biomarker testing specific to oncology trials.
• Exceptional project management and communication skills, with the ability to work collaboratively in a multidisciplinary environment.
• Strong organizational, analytical, and problem-solving skills, with the ability to work independently and thrive in a dynamic, fast-paced environment.
• Familiarity with clinical trial data systems, Electronic Data Capture (EDC), and related applications is preferred.
• In-depth knowledge of clinical trials, drug development processes, Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), regulatory requirements, and Good Data Management Practices.

Location: US Remote candidates must reside in the East Coast Time zone.

About You

• You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment
• You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving
• You are a generous collaborator who can work in teams with diverse backgrounds
• You are determined to do and be your best and take pride in enabling the best work of others on the team
• You are not afraid to 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 leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you’re in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate.

About Genmab

Founded in 1999 in Copenhagen, Denmark, Genmab is an innovative biotech company that has become a leader in antibody biology and innovation. Our product pipeline and next-generation antibody technologies are the result of our strong company culture, a deep passion for innovation, and desire to transform cancer treatment and serious diseases.

When you work with us, you’ll be part of a warm, fun, dynamic community, and team up with some of the best, most authentic individuals in locations around the world, who care deeply and share in a relentless drive to innovate and create transformational medicines. People who are candid, impact-driven, and a little unconventional; who seek out and embrace the opportunity to build new and bold futures within a rapidly growing and innovative biotech company; who bring their full selves to work and show up for each other - rolling up their sleeves to get the job done. This translates into a place where you can be authentically you; are empowered to innovate, build solutions, and execute; feel cared for and supported in growth; and are a critical part of changing the lives of patients around the world through transformative cancer treatment.

Our commitment to diversity, equity, and inclusion

We are committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success. No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, or genetic information. Learn more about our commitments on our website. 

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).