Director Clinical Data Management

Job description

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! Overview: The Director, Clinical Data Management, is operationally responsible for the oversight of Clinical Data Management activities related to the effective planning and timely delivery of complete, high quality and reliable clinical trial data. The Director, DM will provide oversight to ensure that end-to-end data management activities are consistent across the portfolio. The employee will also provide input to/support Genmab clinical drug development programs to ensure data management excellence. In conjunction with the Senior Director, DM, the Director DM contributes to and supports the strategic direction of the Clinical Data Management functional area and ensures activities and processes support the efficient and effective execution of clinical trials. They support the development of standards, provide system oversight support and support digital security strategies as well as drive/support audit/inspection readiness activities. Furthermore, it is expected that the employee will lead/support and facilitate process optimizations and process development within the department and within Clinical Operations in alignment with ICH-GCP and relevant guidelines. This includes, but is not limited to, writing and contributing to Genmab SOPs, procedures and guidelines within Clinical Operations and across functional areas. The Director DM will also be responsible for activities related to outsourcing of DM activities. They will ensure establishment of relevant processes to ensure oversight of data management vendor partners to empower high quality standards and performance. The Director is expected to work in close collaboration with other functional areas within Development Operations and Clinical Development to support cohesive end to end DM processes across vendors. The employees will be part of one or more Partnership Operational Committees with vendors and be responsible for review and establishment of state-of-the-art DM process improvements to build efficiencies and improve data quality of data management deliverables. The employee will be part of the extended DM leadership team and which supports the overall strategy for the department, defines the overall operational strategy, unified objectives and areas for development of Clinical Operations. It is expected that the Director, DM drive work order review activities within the data management area and support program budget oversight activities. Furthermore, the Director, DM may be responsible for leading, managing and developing employees in Clinical Data Management and to ensure that the employees competencies reflect their responsibilities, as outlined in their job descriptions. Through empowerment, they will utilize the full potential of their employees and ensure employees are held accountable for their deliverables. On the more personal level it is important that you challenge and improve current processes and support new working methods and working styles. Responsibilities/tasks : As a Director, Data Management, the employee Together with the Senior Director, DM and HoF DM, contributes to and drives the strategic direction of the Clinical Data Management functional area Contributes to the overall strategy, unified objectives and areas for development of Development Operations Ensures data management activities and processes support the efficient and effective execution of clinical trials. Leads/contributes to standardization activities across the portfolio Drives and supports development of systems and processes within Data Management Ensures end-to-end data management consistency across the portfolio Responsible for driving the selection, collaboration and oversight of vendors related to data management activities Drives/supports vendor qualification (Request for proposal, bid defense meetings etc.) for data management related activities and defines/specifies scope of work for functional tasks Establishes relevant processes to ensure oversight of data management vendor partners Leads/participates in audits and inspections as applicable Ensures timely response to audit/inspection including carrying out a comprehensive root cause analysis and share learnings across trials as applicable Develops and maintains expert competences within Clinical Data Management. Follows scientific, process and technical progress within the field of clinical data management and advises of new methodologies that may support innovation and improve efficiencies. Leads and actively contributes to development, review, implementation and improvements of departmental processes, policies, standard operating procedures, training, and work guidance as applicable. Acts as a role model Proactively engages in department activities Arranges lessons learned to share learnings Leads various initiatives within the department and across departments Proactively contributes to support a global organization Supports a continuous improvement mindset to ensure effectiveness of data management processes Supports the effectiveness of a global Development Operations organization using an outsourced model by developing new and “innovative” ways to work with internal and external partners Supports the expansion of Development Operations across sites and supports the development of Clinical Operations personnel globally. Supports system level risk assessment activities Supports ongoing review and oversight of vendor performance not limited to KPI/KQI review Ensures compliance with Genmab Code of Business Ethics Supports workorder review and budget oversight activities and process development within the department Acts as DM representative in various internal cross functional workstreams and initiatives In the role of Partnership Operational Oversight Committee member, the employee: Supports the development of the DM partnership relationships and effective collaboration with CROs/Vendors Supports CRO governance by attending and actively participating in Partnership Operational Oversight Committee Meetings; communicates POC Meeting actions and decisions within ClinOps and other stakeholders Ensures DM operational excellence and implementation of best practices Ensures cross-trial consistency across studies conducted by the same DM CRO Ensures timely resolution of operational issues by POC; Ensures timely escalation of unresolved issues to the Steering Committee/Management Ensures alignment of processes between vendor and Genmab SOPs Leads meetings with Genmab DMs to ensure consistency and communication of issues across trials Ensures Partner Operational Manuals are maintained, as applicable As a Project Data Manager Lead, the employee, if applicable: Ensures consistency of data management processes and data handling across trials within a project Ensures alignment of Trial DMs within a project by driving alignment meetings within the data management group Provides project-level DM expertise Act as Trial Data Manager support/backup Ensures trial related data management activities (including planning, data collection, data cleaning a