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. Copenhagen, DK candidates will be hybrid.

For US based candidates, the proposed salary band for this position is as follows:

$114,375.00---$190,625.00

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 bonuses.

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

Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. 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 locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan.

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 https://www.genmab.com/privacy.

Please note that if you are applying for a position in the Netherlands, Genmab’s policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.

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