Senior Manager Global Site Start Up Business Services

Role Summary

The Senior Manager Site Start Up (SSU) Business Services will identify, implement, and optimize solutions to enhance SSU efficiency and effectiveness. The role focuses on analyzing current processes, introducing tools and technologies, and fostering cross-functional collaboration to streamline SSU operations and achieve organizational goals. The position requires 4 days onsite per week in an office location (not fully remote).

Responsibilities

• System And Tool Management: Ensure SSU tools and systems support business operations; collaborate with stakeholders to identify improvements and align tools with goals; coordinate updates to enhance workflows; provide guidance to the SSU team in tool use.
• Business Needs Assessment: Collaborate with SSU leadership to identify gaps and inefficiencies; gather requirements and feedback to prioritize tool and system development.
• Innovation And Development: Design and propose innovative tools and solutions; partner with GDIT, DADs teams, or other departments to develop and implement new tools; ensure solutions are scalable and user-friendly.
• Reporting And Analytics: Maintain and improve SSU reports; develop new reporting mechanisms to support data-driven decisions.
• Collaboration And Communication: Serve as primary liaison between SSU and technical teams; facilitate training and user adoption for new tools; promote continuous improvement.
• Continuous Improvement: Shape Veeva and other Regeneron tools to align with evolving standards and regulations; stay updated on industry trends and recommend enhancements.
• Leadership & Team Collaboration: Lead and support cross-functional meetings; present to committees as needed; manage, mentor, and train team members; travel up to 25%.

Qualifications

• Relevant experience with Clinical Trials, documents, and responsibilities internal and external to the Sponsor
• Experience or familiarity with Veeva Vault Clinical modules and existing functionality
• Subject Matter Expertise in CTMS, TMF and Organization/Person Profile Management
• Ability to communicate complex issues to internal and external partners to drive effective decision-making
• Ability to prioritize multiple important tasks and maintain high quality of work while communicating impact on timelines or quality
• Detail-oriented, adaptable, and able to operate in a multi-disciplinary environment
• Cross-functional coordination skills to resolve issues across departments
• Problem solving and decision-making skills; proactive in analyzing and synthesizing problems
• Risk management skills based on thorough business analyses
• Project management leadership capabilities
• Advanced Excel skills (pivot tables, complex formulas, macros)
• Fundamental understanding of programming concepts (e.g., SQL, Python) is preferred
• Management of direct reports is preferred

Education

• Bachelor's degree required; 8+ years of relevant clinical trial experience

Additional Requirements

• On-site work required (4 days per week)
• Travel up to 25%