Clinical Trial Manager

At Genmab, we are dedicated to building extra[not]ordinary futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals' unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees.
Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so.
The Senior Clinical Trial Manager (CTM) plays a key role in supporting Clinical Trial Teams (CTT) and ensuring smooth trial operations. CTMs may be assigned various tasks to support clinical trial planning, execution, and oversight of clinical trials to ensure they are conducted in compliance with regulatory requirements, Good Clinical Practice (GCP), and clinical trial protocols. The CTM works cross-functionally with study teams, investigators, and vendors to ensure trial objectives are met on time and within budget. Senior Clinical Trial managers are expected to assume roles and responsibilities with more autonomy.
Trial Planning and Oversight
Develop and manage operational plans, charters, and manuals to support trial execution in compliance with regulatory and internal standards. Coordinate the development of and manage updates of the Trial Oversight Plan
Review of the Clinical Trial Application submission package as well as supporting the response to Health Authority questions
Act as a key liaison between internal stakeholders and CROs to oversee sponsor oversight visits and ensure quality and compliance across all activities.
Site Selection and Management
Vendor Management and Oversight
Monitor and manage vendor deliverables across trial operations, ensuring alignment with trial goals and timelines
Maintain relevant sections in Clinical Trial Management Systems and Tools
Drive the Operational Data Base review for the trial
Engage in Risk Based Quality Management activities to enhance data quality and monitoring practices, addressing potential risks proactively.
Responsible for maintenance of the Clinical Trial Team issue log in collaboration with Global Clinical Trial Manager
Support GCTM in assessing key performance indicators (KPIs) at the trial level and manage escalation procedures for internal and external stakeholders.
Oversee the tracking and reconciliation of trial-related items, such as scans and blood samples, ensuring trial data accuracy and completeness during trial closeout.
Bachelor's or Master's degree with relevant specialization; Master's degree preferred
Significant experience leading and managing clinical trials
Some experience managing/guiding internal (cross-functional) and external (CRO) teams
Pharmaceutical industry experience with knowledge of ICH/GCP Regulations required
~ Oncology or TA specific drug development experience and various phases of development preferred
~ Developing skills in project management and knowledge of tools and processes
~ End-to-end trial planning and execution knowledge proficient
~ ability to lead and collaborate with cross-functional teams,
~ strong trial planning and budget management skills,
~ Proficient in outsourcing and vendor management.
~ Experience managing trials in global settings, with the ability to oversee complex, multi-regional operations.

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
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.
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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.