IRT Manager

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 IRT Manager supports Global Clinical Drug Supply. Responsibilities IRT Project (i.e., Trials) Management Responsible for the lifecycle (set-up, maintenance, and decommissioning) of trial specific IRT systems including: Plan and coordinate the IRT implementation (initial/amendments), design requirements, UAT planning & execution, integrations, documentation and training in accordance with trial protocol and timelines with the relevant cross-functional stakeholders Enforces the use of IRT system standards Mitigates risk related to IRT system implementation through proper risk assessments Manage and maintain internal and external stakeholder’s expectation for IRT service and system delivery undefined Manage multiple projects concurrently, managing project schedules, and ensuring quality deliverables in a dynamic environment Communicate effectively with stakeholders on project status and coordinate activities with the clinical trial teams, as necessary Participates in or leads Genmab operational planning sessions undefined IRT Vendor Management Provide trial specific inputs to KPIs & metrics for trend analysis of potential and current risks/issues Participate in IRT vendor operational oversight activities for assigned clinical trials, as appropriate Collaborate closely with IRT vendor project manager and operational team members for assigned trials Provide inputs and/or participate for IRT vendor audits and inspection readiness activities, and assist with investigations and/or quality related events for IRT Provides support for problem resolution, root cause analysis, corrective actions between IRT vendor and clinical trial teams undefined Continuous Improvement Provide input areas for continuous improvement Support assigned project improvement activities Provide mentoring for associate level team members as well as facilitate cross functional training for improvement/initiative rollouts May provide support for the creation / maintenance of documentation, such as, but not limited SOPs, work instructions, and job aids Other Responsibilities Ensures the quality and inspection readiness of all Genmab IRT systems Supports the records retention and clinical data maintenance Responsible to be compliant with Genmab´s quality system Provide mentoring and training to IRT team members, as appropriate For US based candidates, the proposed salary band for this position is as follows: $101,120.00---$151,680.00 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 precisi