For our EU regional headquarters (position can also be based in an EU affiliate) we are seeking highly qualified candidates to fill the position:

Senior Manager (m/f/x) DSS DEN Systems and Technology

 
The Position:

Support the definition and execution of the DSS (Data and Statistical Sciences Centre for RWE and EG) systems and technology strategy, focusing on non-R&D patient-level data lifecycle management (including RWD), value creation, and ensuring system lifecycle compliance with regulations and standards. Collaborate with stakeholders and vendors to deliver business-aligned technology solutions and driving operational excellence in clinical technology.

Roles and Responsibilities:

• Develop and implement DSS cross-functional technology infrastructure strategy, ensuring alignment with business needs and stakeholder engagement, including Clinical Data Science, Data Engineering, Statistical Programming and Biostatistics
• Contribute to global DSS vision and strategy focusing on innovation, technology, data governance, harmonization, and cost efficiency.
• Represent DSS in company initiatives, committees, and working groups related to technology solutions and data governance.
• End-to-end system life-cycle management, including system administration and changes control
• Co-author and oversee compliance of global standard operating procedures (SOPs) for DSS systems and processes.
• Lead functional and multidisciplinary project teams to deliver DSS technology initiatives.
• Manage and optimize DSS systems usage by internal teams and external vendors, ensuring regulatory and policy compliance.
• Assist in vendor management including negotiations, budget monitoring, and vendor qualification for technology and data services.
• Drive innovation and operational excellence by identifying improvement opportunities and implementing best practices globally.
• Facilitate collaboration with regional and global stakeholders to promote harmonization and best practices throughout the drug development lifecycle.

Personal Skills and Professional Experience:

• Strong expertise in cross-functional clinical technology solutions (e.g., Metadata Repositories, EDC/eCOA, Statistical Computing Environments, Clinical Data Repositories) and related industry guidances (GxP, Data Governance, GAMP), regulations (GDPR), and standards (CDISC).
• BSc or MSc (preferred) in Statistics, Computer Science, or related fields with several years of  experience, including a few years in drug development or post-marketing within Clinical Research, Pharmaceutical, CRO, or Medical Device settings
• Profound knowledge in managing cloud-based clinical technology projects and Business Process Management, with solid background in technology transformations, agile project management, and vendor management.
• Preferable experience in line management and leadership roles.
• Therapeutic area experience in Oncology or Cardiovascular clinical programs, including late-phase project technology requirements.
• Project Management qualification is preferred; strong negotiation, remote collaboration, and communication skills in English.
• Deep understanding of Data Integrity, GDPR principles, and clinical research standards.
• Proven entrepreneurial mindset with leadership, proactive problem-solving abilities, and solid knowledge of clinical study design, conduct, and execution.