Data Manager, External Data Lead at Genmab in Princeton, New Jersey

Job Description:

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
The Data Manager, External Data, is integral to our Clinical Data Management team, contributing to the oversight of external data collection and management in line with industry and regulatory standards. Responsibilities include eTMF filings, managing database access, report generation, and monitoring deliverables. This role plays a crucial part in enhancing external data management practices, guided by senior staff, and involving data from third-party providers such as laboratories, eCOA providers and technology vendors. This position offers a unique opportunity to develop expertise in data accuracy and consistency under expert mentorship.

Responsibilities

• Assist the external data team-including Acquisition Leads, Quality Managers, and SMEs in Imaging, Labs, ePRO, and IRT-in managing tasks such as data transfer specifications, vendor setup and management, data reconciliation, and eTMF submissions, ensuring timeliness, budget adherence, and compliance with regulatory standards, Genmab SOPs, and ICH-GCP.


• Assist in the oversight and review of data delivered by third-party external providers, aiming for high-quality data collection and testing services.


• Collaborate with internal stakeholders (e.g., Biomarker Operations, Data Management (DM), Data Analytics, Medical Statistics) and external partners to support the data collection strategy, ensuring alignment with trial objectives.


• Facilitate database access requests, ensuring effective communication and involvement of all relevant stakeholders.


• Contribute to tracking team deliverables, maintaining oversight of documentation, and ensuring inspection readiness.


• Participate in the development and maintenance of third-party data reconciliation plans in collaboration with EDQM and external data cleaning activities.


• Support the DM CROs in the quality reconciliation of external data, ensuring its seamless integration into study databases.


• Participate in cross-functional team efforts to efficiently resolve data issues alongside external vendors and DM CROs.


• Assist in ensuring the timely delivery of external data by helping oversee timelines and deliverables.


• Support process improvement and knowledge sharing initiatives within the data management and external data teams.

Requirements

• Bachelor's or Associate's degree in science/related field or relevant experience


• A minimum of 3 years of experience, with 2 years of industry experience (pharmaceutical, biotech, CRO), preferably including oncology trials.


• Basic knowledge of external data management, interest in vendor management


• Exposure to clinical data management in research environments, eagerness to learn, especially in oncology trials


• Understanding of clinical development and ICH-GCP


• Strong organizational and planning skills


• Effective problem-solving and decision-making


• Excellent communication skills


• Detail-oriented with a quality-focused mindset


• Proactive, accountable, with a willingness to learn


• IT and data management systems familiarity


• Enthusiastic about working in a dynamic environment, ready for growth


• Knowledge of clinical trial data systems and EDC (advantageous)


• Understanding of clinical trials, GCP, SOPs, and regulatory requirements, with a commitment to professional development

• In the US this position is remote, with a preference for candidates in the Eastern Time Zone, offering a flexible work environment that supports learning and professional development.

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

$0.00---$0.00

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.