Vai al contenuto principale

Clinical Business Process Manager

Genmab is focused on the creation and development of innovative and differentiated antibody products, with the aim of improving the lives of cancer patients. 

The Role

If you are looking for the next step in your career, have process development and systems experience, and want to have influence on how Genmab operationalizes trials in the future, then you might be our next colleague to join Clinical Operations!

As Clinical Business Process Manager, you will represent, support, and collaborate with all functions within Clinical Operations.  It is expected that you drive the transformation of Clinical Operations with a strong focus on optimizing the way we work to ensure compliant, high quality, and efficient processes across all trial phases and functional areas. You will work in close collaboration with the Clinical Operations Leadership Team (COLT) and Extended-COLT and Clinical Oversight Lead (COL) ensuring that the processes within Clinical Operations are compliantly anchored in the overall departmental strategy.

In this role, you will drive strategic and operational optimization projects within the department and setup workshops and lessons learned with internal and cross-functional stakeholders, vendors, and strategic partners to continuously map and optimize processes within Clinical Operations. You will support compliance and risk management initiatives and drive input to various systems/dashboards/applications to support oversight activities and data visualization within the department. Furthermore, you will work closely together with various stakeholders to drive the development and evaluation of quality measurements within the department. Also, you will act as a subject matter expert on behalf of Clinical Operations and may be responsible for supporting the development, writing, and review of Genmab standard processes (SOPs), procedures and guidelines, and templates together with R&D Clinical Development. 

In collaboration with key stakeholders, you will support inspection readiness for internal audits and Health Authority inspection activities ensuring Clinical Operations’ preparedness and compliance and

support team members in connection to inspection/audit not limited to: development of

inspection/audit material, participation and presentation during audits/inspection, responding

to audit and inspection findings. Lastly, you will participate in/drive relevant departmental activities as applicable, eg, due diligence activities, scientific forums/workshops/learnings, lead/contribute to knowledge sharing sessions, participate in the development and implementation of new methodologies and procedures to ensure Clinical Operations’ work is of high quality and in compliance with processes.

Your position will bring a high level of visibility in the organization, as you will collaborate with several key stakeholders across Clinical Development to ensure focus on process work through continuous stakeholder management and communication. The successful candidate will have strong analytical skills, high quality standards, and a track record of meeting deadlines. In addition, it is essential the candidate is well-organized, proactive, and flexible, and has the ability to work on multiple tasks simultaneously. Furthermore, you thrive working in an international environment, characterized by on-going changes of procedures, systems and processes.


Qualifications

  • Preferably prior experience as a process manager or consultant in implementing and anchoring operational excellence initiatives within the pharmaceutical industry
  • Experience with process optimization
  • +5 years pharmaceutical industry experience
  • Experience within clinical trials is preferred, but not required
  • Good understanding/knowledge of regulatory requirements and drug development processes, GCP/GXP, regulatory requirements, and guidelines associated with regulatory documents
  • Excellent stakeholder management skills
  • Highly organized with the ability to manage multiple conflicting deadlines and competing priorities
  • Experienced in driving change and facilitating cross-functional workshops
  • You can work independently, with a positive, can-do-attitude
  • Demonstrate a structured and analytical approach
  • Enthusiastic and comfortable cooperating and communicating across different functional roles
  • Proficiency in the use and understanding of computer software e.g. word processing, graphics, and document management systems

Moreover, you meet the following personal requirements:

  • You are capable of working on multiple tasks and shifting priorities, and leading cross-functional teams under strict timelines.
  • You are motivated and detail-oriented.
  • You have the ability to work across all trial phases and prioritize your own tasks.
  • You are a dedicated team player and a great communicator with excellent oral and written communication skills.
  • You are proactive and open-minded
  • You have a quality mindset and thrive in a fast-paced and changing environment.
  • You are result- and goal-oriented and committed to contributing to the overall success of Genmab.

 

Degrees of interest: +5 years pharmaceutical industry experience

Altre offerte di lavoro di 'WORKINDENMARK'

Director, IT Technical Architecture & DesignManager, System Change & Release ManagementUpstream Processing CMC SpecialistDownstream Processing CMC SpecialistAnalytical CMC SpecialistAssociate Director, Clinical Project LeadMedical Writing ManagerSenior Manager, Medical Writing Document ManagementMedical DirectorSponsor Oversight LeadClinical Trial ManagerSenior Clinical Trial ManagerPrincipal/Senior BiostatisticianDirector, Team Lead, Trial ManagementActive Directory EngineerAnalytics & Visualization LeadBusiness Application Manager, CMCSenior Data EngineerAssociate Director, QA GCP/PVClinical Oversight Data Manager, BiometricsAssociate Director, Alliance ManagementSenior Clinical Research ScientistIAM EngineerCMC Project ManagerSenior Team Lead, IT & Digital ValidationSenior Clinical Trial AssociateAssociate, Artwork and ComplianceSpecialist Stability OperationsCMC WriterSenior Manager, QA GMPStatistical ManagerSenior Manager / Associate Director, Clinical ProgrammingSenior Clinical Start Up ManagerResponsible Engineer for Expansion Projects, Process EngineeringOperational Maintenance EngineerElectrical EngineerManufacturing Project LeadAutomation EngineerContinuous Improvement Partner, QCDownstream Process EngineerPharmaceutical Quality System (PQS) SpecialistManufacturing ScientistLead for Quality DeviationsCMC Project DirectorExperienced Qualification and Validation Professionals for huge projectsProject Manager - PP Project OfficeAssociate Project AcademicLeaders to Associate Manager PipelineQuality Assurance ProfessionalDevelopment Scientist for API Manufacturing DevelopmentPostdoc in X-Ray MicroscopyPostdoc in Human Mucosal ImmunologyPhD scholarship in Enzyme Assisted CO2 CapturePhD Scholarship in Digital Phenotyping for Comorbid Mental HealthPhD position on Development of Digital Twins to Optimize Urban / Industrial Water Treatment SystemsSenior Commissioning & Operations Engineer for Cutting-Edge CO2 Capture and Utilization PlantsTravel-happy CO2 Capture TechnicianPostdoc in Biochemical Engineering or BiotechnologyDTU Tenure Track Researcher(s) in Organic Coatings TechnologyFermentation specialistPhD scholarship in Mucosal ImmunologyProcess Scientist and Process EngineersNewly graduated Engineers