Senior Clinical Trial Manager

Senior Clinical Trial Manager

At Genmab, we are dedicated to building extraordinary futures, together, by developing antibody products and groundbreaking, knock-your-socks-off 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.

Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. 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.

Does this inspire you and feel like a fit? Then we would love to have you join us!

Overview

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.

Roles & Responsibilities

Trial Planning and Oversight :

• Develop and manage operational plans, charters, and manuals to support trial execution in compliance with regulatory and internal standards.
• Review of protocol and protocol amendments.
• Coordinate the development of and manage updates of the Trial Oversight Plan.
• Review of the Investigator's Brochure from DevOps perspective.
• Review of the Clinical Trial Application submission package as well as supporting the response to Health Authority questions.
• Review of Regulatory Green Light packages.
• Review the Development Safety Update Report.
• Develop the Global Master ICF.
• 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 :

Trial Execution and Monitoring :

Requirements :

Core Skills and Competencies :

For US based candidates, the proposed salary band for this position is as follows : $122,000.00 $183,000.00. 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 :

About You :

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