Senior Manager Global Site Start Up Business Services

Role Summary

The Senior Manager Site Start Up Business Services will play a pivotal role in supporting the Site Start-Up (SSU) team by identifying, implementing, and optimizing solutions that enhance business efficiency and effectiveness. This role will focus on analyzing current processes, introducing innovative tools and technologies, and fostering cross-functional collaboration to streamline SSU operations and achieve organizational goals.

Responsibilities

• Ensure that SSU tools and systems are effectively supporting business operations and meeting team needs.
• Work closely with stakeholders to identify opportunities for improvement and ensure tools are aligned with organizational goals.
• Coordinate updates and enhancements to existing tools to improve workflows and address evolving business needs.
• Provide guidance and support to the SSU team in using tools effectively, helping resolve any challenges they encounter.
• Collaborate with SSU leadership and teams to identify gaps, challenges, and inefficiencies in current processes.
• Gather requirements and feedback from stakeholders to prioritize tool and system development efforts, ensuring alignment with SSU objectives.
• Use creativity and problem-solving skills to design and propose innovative tools and solutions that address business needs and improve process efficiency.
• Partner with GDIT, DADs teams, or other relevant departments to develop and implement new tools and systems that drive operational excellence.
• Ensure new solutions are scalable, user-friendly, and aligned with SSU goals and industry standards.
• Maintain and improve existing SSU reports, ensuring data accuracy, relevance, and actionable insights.
• Develop new reporting mechanisms to support data-driven decision-making and process optimization.
• Serve as the primary point of contact between SSU and technical teams, ensuring clear communication of requirements, timelines, and priorities.
• Facilitate training and user adoption for new tools and systems within the SSU team, fostering a culture of continuous improvement.
• Drive continuous improvement by proactively shaping Veeva solutions and other Regeneron tools to create strategies to align with evolving industry standards and regulations, ensuring sustained compliance and strong operational performance.
• Stay updated on industry trends and emerging technologies relevant to SSU operations, recommending enhancements to tools and processes to ensure efficiency and effectiveness.
• Lead and support meetings, sending meeting invites, setting agenda, creating minutes, and following up with actions with cross-functional teams, as required.
• Present to the Regeneron Steering Committee and request endorsement of system enhancements, as needed.
• Manage, mentor, train and support other members of the team as required.
• May require up to 25% travel.

Qualifications

• Relevant experience with Clinical Trials, documents and responsibilities internal and external to the Sponsor
• Relevant 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 driving effective decision-making is required.
• Ability to prioritize multiple important tasks and maintain high quality of work and appropriately communicate items that could impact timelines or quality is required.
• Detail oriented collaborator with demonstrated ability to adapt to change is required. Proven experience in a multi-disciplinary environment is required.
• Cross-functional Coordination Skills - ability to collaborate within own department/function as well as across departments to resolve issues is required.
• Problem Solving / Decision-making - takes an active role in analyzing and synthesizing problems and issues is required.
• Risk Management Skills - evaluating risks based on thorough business analyses is required.
• Project Management - ability to take a leadership role in managing projects is required.
• Advanced Excel skills (e.g., pivot tables, complex formulas, macros) are required.
• Fundamental understanding of programming concepts (e.g., SQL, Python, or similar) is preferred.
• Management of direct reports is preferred.

Education

• A minimum of a Bachelor's degree and 8+ years of relevant clinical trial experience is required.