The IQVIA sponsor-dedicated Clinical Functional Service Partnerships (Clinical FSP) department is supporting our client’s project team in the execution of early clinical trials. Joining our team offers the opportunity to work on innovative projects in a dynamic environment. You will support trial preparation, documentation, and coordination, ensuring compliance with regulatory standards and internal processes. This role combines operational and administrative responsibilities and requires close collaboration with internal and external stakeholders. We currently offer an exciting opportunity to join the FSP team as global Clinical Trial Coordinator ECT (m/w/d) in full-time and work home-based throughout Germany. RESPONSIBILITIES - Coordinate clinical trials in early clinical development for both Sponsor and Study site. - Support Clinical Trial Leaders, Clinical Trial Managers, Clinical Research Associates and Principal Investigators in all study-related activities throughout all study phases (preparation, conduct, close-out). - Prepare and manage clinical trial documentation - Compilation and collection of submission documents. - Maintain trial-specific data and timelines in electronic systems. - Communicate effectively with internal and external partners (e.g., statisticians, data managers, regulatory affairs, investigators). - Organize and monitor study-related activities, meetings, and documentation. - Ensure timely preparation of submission documents for authorities and ethics committees. - Manage essential documents for Investigator Site File (ISF) and ensure Trial Master File (TMF) completeness and compliance. - Act as TMF Records Specialist: oversee TMF strategy, perform quality checks, maintain List of Expected Records, and ensure audit/inspection readiness. - Participate in process harmonization initiatives and support implementation of new systems. - Assist in finalizing Clinical Trial Reports (CTR) and appendices. REQUIRED KNOWLEDGE, SKILLS AND EXPERIENCE - Bachelor’s or higher-level degree in Business Administration, Life Science or equivalent, with experience in clinical trials. - Alternatively, vocational training with extensive experience in clinical and regulatory environments. - At least 5 years’ experience as Clinical Trial Coordinator or within a similar role in clinical research. - Strong knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. - Excellent administrative and organizational skills. - Strong communication and interpersonal skills. - Proficiency in MS Office and eTMF systems (e.g., Veeva, BIRDS). - Fluent languages skills in German on at least C1 level and good command of English. - Ability to work independently, prioritize tasks, and manage multiple projects in a complex international environment. WHAT YOU CAN EXPECT - Permanent employment contract. - In-depth training and mentoring. - Home-Office throughout Germany. - Competitive salary and benefits package. We invite you to join IQVIA! Please apply with your English CV, motivation letter and education certificates and job reference letter. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

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! The Role: The Senior Director acts as a high-level statistical expert supporting the clinical development of compounds as therapeutic area lead, compound lead and/or indication lead for both early and late-stage programs and may also act as trial responsible statistician with responsibilities as described below. The Senior Director contributes to clinical development strategies and plans. Responsibilities: Therapeutic Area Level - Contribute to the profiling of the company, as highly scientific and specialized within the designated therapeutic area - Act as lead and main point of contact related to Statistics within therapeutic area - Ensure oversight and consistency across multiple compounds within therapeutic area Compound/Indication Level - Act as lead and main point of contact related to Statistics for designated compound/indication - Follow scientific and technical progress within the field of biostatistics in drug development and advise of new methodologies that may support innovation and improve efficiencies - Engage with regulatory authorities on compound/indication level discussions - Acts as a role model - Ensures consistency of statistical methods and data handling across trials - Ensures all compound/indication related work and information is shared between biostatisticians involved in the compound and with the vendor - Supports compound responsible programmer in developing an integrated database specification CDT member: - Responsible for giving statistical input to overall strategy and the synopsis development in the CDT - Provide scientific advice to the CDT including design of trials, analyses and analyses requiring advanced statistical methodologies/techniques - Represent the CDT/the company at regulatory meetings, during Key Opinion Leaders meetings, network and/or Partner meetings, as applicable - Drive design and synopsis development together with relevant stakeholders - Ensure transparent communication to relevant stakeholders from the CDT - Ensure availability of integrated database(s), as needed, and planning and conduct of integrated analysis to support development decisions, submissions, and marketing needs - Support development and communication in relation to communication strategy and/or scientific input to presentations, posters, and articles Trial Level - Represent Genmab during meetings/congresses and courses and perform professional networking - Engage with regulatory authorities on trial level discussions - Arranges/attends lessons learned to share learnings - Represents Genmab during Key Opinion Leaders meetings - Ensure biostatistician review of partner synopsis, protocols, statistical analysis plans, results meetings presentations and clinical trial reports - Coordinate data transfers from/to business partners in collaboration with the programmer and the data manager, as applicable Ensures state of the art statistical work which includes but is not limited to: - Applying adequate methods for which a solid scientific foundation exists - Ensure proper documentation of work done - Keep oversight and QC essential documents/data provided by vendors - Ensure trial related work is performed in accordance with Genmab SOP/processes and standards and ICH-GCP CTT member: - Participate and represent Biostatistics - Review and provide input to protocol and amendment development - Perform vendor oversight according to applicable SOPs - Give input to eCRF setup, edit checks, validation plan, protocol deviations classifications, DSUR, IB updates, tables, figures, and listings etc. - Review assay validation reports, as applicable - Perform exploratory analysis, ad hoc analyses, and modelling of data - Review and approve randomization and stratification plans - Perform UAT of Randomization part of the IRT system as applicable - Ensure procedures for blinding are in place as applicable - Support timely delivery of statistical deliverables - Responsible for planning and conducting trial result meetings - Review and approve the CSR - Attend trial and investigator meetings if/as needed Collaboration with Genmab Global Drug Safety: - Participate in definition, review, and approval of data packages for Data Monitoring Committees - Review and approve any amendments, corrections, and updates of data packages CRO selection and collaboration: - Perform vendor qualification (Request for proposal, bid defense meetings etc.) in terms of Statistics and define/specify scope of work for functional tasks - Review scope of work (within own project) in collaboration with relevant stakeholders and review/challenge major work orders (WOs)/change orders (COs)/change notification forms (CNFs) - Attend operational and steering committee meetings, as applicable - Support regulatory submission/filing activities Requirements: - Master's or PhD in a statistical discipline with 15+ years of experience in relevant technical area preferred, or demonstrated capability - Experience in statistical analysis, modelling and simulation and adaptive trial designs - Experience with drug development in biologics, targeted therapies, and companion diagnostics preferred - Experience working with FDA, EMA, and ICH guidance for drug development pertaining to statistics - Experience with the relevant regulatory requirements for biostatistics processes and SOPs - Experience with regulatory submissions including BLAs and previous experience in dealing with Health authorities such as discussions/negotiations in filing strategies - Experience working with SDTM, ADaM, eSUB, and CDISC requirements for regulatory submissions - Experience directing multiple complex projects/studies in a technical capacity - Experience leading and mentoring teams - Proven performance in earlier role/comparable role For US based candidates, the proposed salary band for this position is as follows: $244,240.00---$366,360.00 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: - 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 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 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 LinkedIn and X. 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 Job Applicant Privacy Notice (genmab.com). 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.

• Supports the design and writing of clinical protocols and associated clinical study documents (e.g., ICFs, charters, operational manuals, etc.) • Serves as an expert on the clinical study design (including trial procedures and requirements) and develops training materials to ensure quality execution by the investigational sites. • Supports cross-functional teams with study protocol and related questions and serves as point of contact for managing/answering questions relating to trial procedures. • Provides medical monitoring support or oversight of activities conducted by a CRO, which includes monitoring, cleaning, analyzing, and reviewing efficacy data to establish the presence or absence of trends and follow up as appropriate. • Collaborates on, or lead where appropriate, the writing of clinical sections of key program documents including Investigational New Drug submissions, Investigator Brochures, Clinical Study Reports, and other global regulatory submissions and responses. • Supports clinical development planning by participating in the evaluation of innovative trial designs and provisioning and analyzing data from ongoing and/or completed clinical trials to support future planning. • Maintains awareness of internal and external developments (scientific, clinical, competitive, and regulatory) that could impact the development plan, including attendance at major scientific conferences, participation in competitive intelligence activities, and periodic literature review.

• Provides support across all assigned statistical tasks during the lifecycle of the project • Prepares Statistical Analysis Plans (SAPs) • Coordinates the activities of other biostatistics and statistical programming personnel • Creates or reviews programming specifications for analysis datasets, tables, listings, and figures • Reviews SAS annotated case report forms (CRFs), database design, and other study documentation • Conducts and participates in verification and quality control of project deliverables