Senior Manager, TMF

n we would love to have you join us!

The Role

The role is responsible for supporting the Trial Master File (TMF) in alignment with Genmab's procedural documents, ICH-GCP guidelines, and regulatory authority expectations. This position is not study-specific but instead provides overarching support across all Genmab studies. A key responsibility is to ensure TMF inspection readiness and to assist the Director, TMF Team Lead with tactical implementation strategies related to the electronic TMF (eTMF). The role will also provide guidance to TMF Oversight team members as needed.

In this position, the employee will act as a TMF Subject Matter Expert (SME), driving critical TMF initiatives and fostering continuous improvement with both internal and external stakeholders.

Responsibilities

• Act as backup for the TMF Business/Data Owner and TMF Archivist; approve Business/Data Owner tasks as appropriate.

• Drive TMF oversight across all Genmab trials to ensure inspection readiness (quality, completeness, and timeliness of filing); monitor KQI/KPI dashboards and reports for trends and outstanding tasks.

• Support eTMF migrations, integrations, archival, and AI initiatives, including chatbot support and data visualization dashboards in collaboration with key stakeholders.

• Respond timely to process-related questions (e.g., via mailbox(s)/emails).

• Support functional areas by addressing TMF SME questions, providing updates, and developing workarounds as needed.

• Create content and conduct internal/external TMF trainings.

• Develop TMF processes, plans and templates.

• Support on audit trail reviews, user access reviews, and controlled template management.

• Oversee CRO partners to ensure eTMF tasks are completed per Work Orders/Change Orders, SOPs, and Work Instructions.

• Support the TMF Business Owner with eTMF enhancements, strategic change controls to ensure alignment with business needs and regulatory requirements.

• Serve as Vice Chairperson on the TMF Health and TMF Indexing Key committee, which will include select request reviews and communicating major updates as needed.

• Participate and present during inspections/audits as a representative from TMF.

• Following inspection/audit, support with TMF document collection, post-inspection follow-up, CAPA activities, and action items.

• Represent TMF on governance forums and departmental initiatives (e.g., due diligence, forums/workshops, knowledge-sharing sessions, new methodology/procedure development).

• Stay current with ICH-GCP, regulatory standards, and TMF industry updates to ensure ongoing compliance and best practices.

• Support and mentor the TMF Oversight team members.

Requirements

• Bachelor's Degree required, life sciences preferred.

• Minimum 8 years of experience working in clinical research, eTMF preferred.

• Expert knowledge of eTMF systems, Veeva Vault preferred.

• Expert knowledge of the eTMF index structure (CDISC TMF Reference Model).

• Vast experience with all phases of the drug development processes (discovery to market), including key clinical trial documentation, Oncology area experience preferred.

• Previous experience with WO, TMF plans, TMF reviews and KQI/KPI assessments.

• Expert knowledge to be able to perform their role in accordance with ICH-GCP, internal SOPs and guidelines.

• Expert knowledge of regulatory requirements and drug development processes, Good Clinical Practice (GCP), regulatory requirements and guidelines associated with clinical trial and regulatory documents (e.g., protocols, investigator brochures, and clinical study reports).

• Vary experience in driving process improvement through insights, previous experience etc.

• Ability to creative pragmatic problem-solving approaches to cut through ambiguity, complexity, and deliver tangible results at a senior level.

• Strong ability to build strong internal and external stakeholder relationships.

• Powerful communicator with the ability to consolidate and convey complex information with a clear voice.

• Ability to create and deliver effective oral presentations and educate stakeholders.

• Strong interpersonal and communication skills in English.

• Active listener with excellent analytical and documentation skills ensuring attention to detail and the highest level of accuracy.

• A team player but also able to work independently.

• Able to demonstrate leadership skills.

• Fluent English (oral and written).

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:

$116,000.00 - $174,000.00

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 discretionary bonuses and long-term incentives.

When you join Genmab, you're joining a culture that supports your physical, financial, social, and emotional wellness. Within the first year, regular full-time U.S. employees are eligible for:

• 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

About You

• 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!

Locations

Genmab maximizes the efficiency of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are crafted as open, community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether you're in one of our 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 to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. 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 international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X.

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).

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.