Dss Director Data Engineering System and Technology
vor 4 Wochen
Actively contribute to define and execute the vision and strategy for global DSS technology, covering the full data life-cycle and value creation.
Partner with stakeholders to execute technology initiatives and consult on technology aspects, including vendor management.
Manage team performance and development, utilizing expertise in clinical technology solutions and process excellence.
**Roles & Responsibilities**:
- **DSS Technology Responsibilities**
- Actively contributes in developing DSS strategy for cross-functional technology infrastructure. Ensure appropriate and proactive networking with key stakeholders, understand incoming business needs, implement DSS systems vision and strategy.
- Contributes to the development and implementation of global DSS vision and strategy. Identifies innovation, technology, Data Governance/Stewardship and business needs to proactively meet customer expectations, as well as improve harmonization and efficiency for cost savings and accelerated worldwide product development and access.
- May represents DSS in company initiatives, committees and working groups related to technology solutions, data governance and associated processes.
- Administrative responsibilities for recruiting, retaining, coaching, developing, and managing individual contributors within the DSS-DEN system function.
- Author or initiate writing of global system related standard operating procedures. Oversee and ensure compliance of system related standard procedures and processes.
- Will lead functional and/or multidisciplinary teams working on projects and initiatives.
- The position holder will have strong verbal/written skills, analytical, organizational, and interpersonal skills and is able to work effectively with people at different levels and from different disciplines and cultures.
- **Portfolio Lead for Data Engineering**
- Contributes to the development and is responsible for execution of DSS systems strategy to exceed/achieve quality, time, and cost objectives.
- Plans/directs the selection and use of DSS systems for outsourced and/or insourced activities.
- Provides oversight for system use by internal resources, CROs, and other third-party vendors to ensure compliance with external/internal standards, GxPs, applicable regulatory guidelines, Policies, SOPs, and other relevant guidelines.
- Functions as DSS systems escalation point for all studies within the assigned program(s).
- Proactively identifies and manages risks at the functional level and/or for assigned programs, and/or initiatives.
- Partners with internal and external stakeholders to optimize DSS technology, processes, and standards.
- Participates in audits and inspections to represent line function expertise and ensures inspection readiness related to systems and Data Governance.
- Supports standards management.
- **External Vendor Management**
- Responsible for all the Vendors providing technology solutions directly to DSS.
- Manage higher-level negotiation and provides oversight of budget, resources and timelines with technology providers for multiple projects across the department and ensures timely delivery of high-quality deliverables at reasonable cost.
- Supports vendor qualification and oversight for CROs, technology and data related vendors in DSS functional or drug program level outsourcing.
- **DSS Department Innovation and Operational Excellence**
- Lead global DSS technology and Data Governance innovation for activities outside the Regulatory perimeter.
- Contribute to develop and implement global vision and strategy to leverage systems and data governance innovation and operational excellence. Identifies opportunities, creates and leverage network with internal / external stakeholders to drive systems, processes and tools based on emerging trends, technology and best practices.
- Leads global/regional implementation of improvements and makes recommendations for regional/global implementation.
- Leads global DSS initiatives to improve the harmonization and efficiency of processes by coordinating the work of an assigned team of experts.
- Actively contributes to the review of best practices within the function.
- Coordinates with key stakeholders regionally/globally to optimize cross-functional interfaces and collaboration.
- Utilizes systems expertise to promote best practices throughout the Drug Development lifecycle.
- Develops and maintains peer relationships with thought leaders in technology and Data Governance and related areas.
**Personal Skills and Professional Experience**:
- Minimum 10 years in clinical data and statistical sciences and related systems experience in pharmaceutical industry, medical device, or similar environment (e.g. CRO).
- Extended knowledge in cross-functional clinical technology solutions (incl. Metadata Repositories, EDC/eCOA, Statistical Computing Environments, Clinical Data Repositories etc.) and related process excellence, industry guidances (e.g. GxP, Data Governance, GAMP),
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