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.

Overview:

The role will support study-specific clinical oversight of the eTMF as established within Genmab’s procedural documents, GCP-ICH guidelines, and regulatory health expectations. In this position, the employee will also be responsible for supporting eTMF inspection readiness activities and acting as an eTMF Subject Matter Expert (SME) to our internal and external stakeholders.

Responsibilities

The key accountability of this role is to support eTMF inspection readiness activities and help drive internal and external stakeholders to be eTMF compliant., by:

• Remaining up to date with GCP-ICH guidelines, regulatory standards and TMF industry updates.
• Attending internal and external meetings as needed.
• Coordinating with CRO partners to ensure eTMF tasks are performed per Genmab standards and agreements.
• Assisting with questions from the eTMF Management Mailbox.
• Supporting with the approval of study specific TMF Plans and other study specific TMF related documents.
• Monitoring KQI/KPI and eTMF dashboards/reports for trends and outstanding eTMF tasks regarding quality, completeness, and timeliness.
• Supporting stakeholders with spot checks related questions.
• Assisting with the communication of important eTMF updates e.g., Indexing Key updates, major changes in GenDocs eTMF, CRO agreements related to filing in eTMF.
• Performing audit trail reviews.
• Assisting with and/or performing GenDocs eTMF User Access reviews per SOP.
• Coordinating eTMF oversight activities with internal stakeholders.
• Supporting in the development of inspection/audit material (slides, storyboards, etc.), participate in eTMF inspection/audits as needed.
• During inspections, this role will support document collection and review as needed in addition to the Function Area (FA) SME/representatives.
• Supporting with ongoing study-specific inspection readiness activities e.g., confirming CRO actions are completed by performing cross-checks.
• Supporting eTMF post inspection/audit action items.
• Supporting the development, testing, and training of eTMF AI initiatives.
• Participating in cross-functional working groups as needed.

Requirements

• Fluent English (oral and written).
• Bachelor's degree preferred. Minimum Associate's Degree required.
• 2 years of experience working in clinical research, TMF required.
• Experience working with an eTMF system preferred.
• Understanding of the eTMF structure (CDISC TMF Reference Model) preferred.
• Strong knowledge of process management.
• Prior experience working in clinical research trials and understanding of the drug development processes.
• Basic understanding of the eTMF structure (CDISC TMF Reference Model).
• Previous experience with document creation and document management.
• Operational knowledge to be able to perform their role in accordance with ICH-GCP, internal SOPs and guidelines.
• Proficiency with MS Office suite (e.g., Outlook, Word, Excel, PowerPoint, SharePoint, Teams, Forms).
• Ability to build stakeholder relationships.
• Process oriented with a quality mindset.
• Strong interpersonal and communication skills in English.
• Active listener with basic analytical and documentation skills ensuring attention to detail and the highest level of accuracy.
• A team player but also able to work independently.
• Comfortable in a fast-paced expanding company environment and able to adjust workload based upon changing priorities.
• Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.
• Goal-oriented and committed to contributing to the overall success of Genmab.

The Employee shall also render such other related services and duties as may be assigned to him/her from time to time by his/her supervisor.

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

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.