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.
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
Collaborate with the CRO and/or internal functions to oversee site selection based on feasibility assessments, aligning site readiness with trial timelines.
Coordinate the review of country-specific informed consent forms with internal stakeholders
Vendor Management and Oversight
Monitor and manage vendor deliverables across trial operations, ensuring alignment with trial goals and timelines
Participate in the selection and approval of key CRO personnel, such as Clinical Leads and trial-specific CRAs, to ensure their expertise aligns with trial demands.
Trial Execution and Monitoring
Responsible for trial specific protocol deviation guidance and ongoing protocol deviation assessments and trend tracking
Ensure ongoing accuracy and completeness of the eTMF, supporting inspection readiness and regulatory compliance.
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.
Participate in inspection readiness activities, support QA in audit preparations, and conduct site visits as needed.
Oversee the tracking and reconciliation of trial-related items, such as scans and blood samples, ensuring trial data accuracy and completeness during trial closeout.
Requirements
Bachelor's or Master's degree with relevant specialization; Master's degree preferred
Minimum requirement: 8+ years in clinical operations
Significant experience leading and managing clinical trials
Experience in leading multiple complex trials, maintenance of trial documentation, CRO engagement, and budget monitoring
Some experience managing/guiding internal (cross-functional) and external (CRO) teams
This role is hybrid and requires 60% in the office.
Core Skills and Competencies
Experience working in a complex, global and matrixed organization required
Pharmaceutical industry experience with knowledge of ICH/GCP Regulations required
Oncology or TA specific drug development experience and various phases of development preferred
Matrix leadership experience (ability to lead without authority) preferred
Experience mentoring others required
Developing skills in project management and knowledge of tools and processes
End-to-end trial planning and execution knowledge proficient
Developing knowledge in
-regulatory submissions, metric development and monitoring,
-written and verbal communication skills,
-negotiation, collaboration and interpersonal skills with ability to work effectively with others at all levels of the organization,
-ability to lead and collaborate with cross-functional teams,
-strong trial planning and budget management skills,
-strong understanding of clinical trial processes, ICH-GCP regulations, and the clinical drug development lifecycle
Proficient in outsourcing and vendor management.
Experience managing trials in global settings, with the ability to oversee complex, multi-regional operations.
For US based candidates, the proposed salary band for this position is as follows:
$,.00 - $,.00 USD
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.