Senior Clinical Trial Manager

Genmab

  • Utrecht
  • Contract
  • Voltijds
  • 23 dagen geleden
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!OverviewThe (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 & ResponsibilitiesTrial 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
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.
About YouYou are genuinely passionate about our purposeYou bring precision and excellence to all that you doYou believe in our rooted-in-science approach to problem-solvingYou are a generous collaborator who can work in teams with a broad spectrum of backgroundsYou take pride in enabling the best work of others on the teamYou can grapple with the unknown and be innovativeYou 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!LocationsGenmab 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 GenmabGenmab 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 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 Genmab.com and follow us on and .Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website .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.

Genmab