IRT 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!

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 stakeholders 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 Genmabs 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:

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.