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 Global Clinical Trial Manager (GCTM) is accountable for the end-to-end delivery of a single or multiple clinical trials from strategy outline through to CSR by leading cross-functional trial specific Clinical Trial Teams (CTT) to deliver clinical trials including managing the trial budget.

The GCTM is accountable for trial deliverables and acts as point person for coordination of the TM team. The GCTM can at all times take the responsibilities of a CTM. If no CTM resource is assigned to a trial the GCTM takes on the CTM role too.

Roles & Responsibilities

Trial Leadership and Management:
Lead the Clinical Trial Team (CTT)
Lead the Trial Management (TM) team
Define and manage CTT goals (together with CTT)
Review and approve protocol and amendment changes
Review Master ICF
Approve operational plans, manuals and charters for the trial
Oversee vendor selection process
Initiate and ensure the accuracy and completeness of initial Work Order (WO) / Change Orders (CO)
Drive country selection process
Coordinate and respond to IEC/IRB comments
Overview of major PDs and PD trending.
Approve data cleaning plans
Work closely with CPL as needed for CST/CDT
Ensure responsibility split is developed and maintained
Review and contribute to CSR as needed
Escalate issues to CPL in a timely manner
Execute operational strategy related to Drug supply
Execute regulatory submission strategy
Execute recruitment strategy


Budget and Planning:
Assist in initial development and Manage trial budget
Plan, implement & ensure maintenance detailed integrated trial timelines from study outline though CSR (Gap: GCTM/CPL need a planner, e.g., MS Project, to show end to end project timelines and to build trust in organization).
Develop initial recruitment projections and strategy
Approve re-baseline recruitment projections in alignment with CPL.
Act as counterpart for CRO PL/PM and approve CV of PL/PM


Risk management:
Conduct study risks identification with CTT & risks management activities
Oversee CTT issue log and issue resolution
Oversee CTT Action/Decision logs are maintained
Assist in preparation for & responses to audits
Ensure CAPAs are in place, if applicable


Competencies
Demonstrated ability to lead & collaborate with cross-functional teams to drive operational excellence
Experience in leading & managing global teams
Experience in mentoring CTMs and CTAs
Planning and budget management skills
Outsourcing and vendor management experience
Ability to anticipate risks and issues with proactivity to offer solutions & to timely escalate issues when needed
Ability to foster a "One Team" spirit, inclusive mindset
Confidence to challenging status-quo thinking and behavior; can work with agility and an innovative mindset
Ability to align with Corporate, Dev Ops, Trial Management, and CDT goals
Excellent written and oral communication skills
Oncology experience strongly recommended


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

$142,500.00---$237,500.00

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...

Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity