Senior Clinical Trial Manager

At Genmab we are dedicated to building extranotordinary 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 Investigators 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 informedconsent 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 andtrend 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 issuelog 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

• Bachelors or Masters degree with relevant specialization; Masters degree preferred

• Minimum requirement: 8 yearsin 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 organizationrequired

• Pharmaceutical industry experience with knowledge of ICH/GCP Regulationsrequired

• Oncology or TA specific drug development experience and various phases of developmentpreferred

• Matrix leadership experience (ability to lead without authority)preferred

• Experience mentoring othersrequired

• Developing skills in project management and knowledge of tools and processes

• End-to-end trial planning and executionknowledge 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

• Proficientin 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:

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 youre 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 youre 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 Genmabs 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 and follow us on LinkedIn and X.

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Please note that if you are applying for a position in the Netherlands Genmabs 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.