IRT Manager, Clinical Drug Supply

IRT Manager, Clinical Drug Supply

Exciting opportunity within Interactive Response Technology (IRT) management in an international biopharmaceutical company

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Genmab is focused on the creation and development of innovative and differentiated antibody products, with the aim of improving the lives of cancer patients. They continue the growth and are now looking for an IRT Manager to join the Global Clinical Drug Supply, CMC Operations team at the Copenhagen office. The team currently consists of 12 employees: 7 in DK and 5 in the US.

As Genmab is moving forward with many late-stage trials in their pipeline, you will be responsible for the lifecycle of trial specific IRT systems including integration to other systems.

With direct report to Head of Global Clinical Drug Supply.

Your main tasks are:

• Responsible for the lifecycle (set-up, maintenance, enhancement, and decommissioning) of trial-specific IRT systems including:
  • Plan and coordinate the IRT implementation (initial/amendments) design requirements, UAT, integrations, and training in accordance with trial timelines with relevant cross-functional stakeholders
  
  
• Support the strategic development of IRT use in Genmab
• Collaborate with internal and external stakeholders, e.g., Scientists, Trial Managers, Data Managers, Clinicians, Vendors
• Ensure IRT systems maintain qualified state throughout the system lifecycle
• Identify and manage changes rolled out by IRT vendors
• Manage and maintain internal and external stakeholder expectations for IRT service and system delivery
• Technical oversight, compliance, qualification, and validation of IRT systems used in Genmab in collaboration with IT, QA, and Vendor
• Ensure the quality and inspection readiness of all Genmab IRT systems
• Support records retention and clinical data maintenance
• Support the Supplier Relationship Management of IRT vendors including contributing to KPI/metric definition and analysis

Your qualifications are several years of experience from a biotech or pharmaceutical company in setting up, validating, and working with IRT systems. Moreover, you possess solid knowledge and experience with regulatory requirements for GxP computerized systems and working with regulatory audit teams.

You have a relevant Bachelor’s Degree or equivalent.

As a person, you are proactive, detail-oriented, enthusiastic, and goal-oriented. You have a high drive motivated by working in a fast-paced environment with tight deadlines. You are a team player with a demonstrated ability to collaborate with a diverse group of internal and external stakeholders to support product development strategy. Finally, you possess strong communications skills.

Genmab offers a challenging position working with highly specialized people across functions in an informal, multicultural, and global environment, with an aim to make a difference in the lives of people with cancer worldwide. The right candidate will have a great opportunity to develop professionally as well as personally and to further the career in other functions within Genmab.

Travelling: Max. 1-2 weeks a year in foreign countries.

Domicile: Genmab’s office in Havneholmen, Copenhagen.

For more details about the job or the company, please contact CEO Jørn Duhn, Unique Human Capital on M: +45 21 75 19 25. All applications must be in English and are treated confidentially.