The Senior Manager who will closely manage the Clinical Trial Management System (CTMS) is central to advancing Regeneron’s document and process management capabilities. With a focus on Veeva Vault Clinical Trial Management System and its connectivity with other Veeva Vault Systems (ie, SSU Module, Site Connect, etc), this role ensures the systems' usability, efficiency, and alignment with business objectives are optimal. The Sr. Manager will also be responsible for the introduction and adoption of relevant technologies that enable efficient business processes.

A day in this role looks like:

CTMS Management:

• Define the business requirements associated with the management and maintenance of clinical trial data within the CTMS, ensuring quality, completeness, and timeliness for study, country, and site operational data.
• Identify interdependencies with other relevant CTMS modules/capabilities related to Study, Country, Site, and Person data capture and management to streamline clinical trial operations.
• Accountable for the creation and management of Control Documents and supporting materials (SOPs, WIs, Business Practice Tools, and Forms) to ensure business processes are repeatable, predictable, and scalable according to the volume of data managed in CTMS.
• Collaborate with GDIT to oversee the CTMS system, ensuring its peak performance, accessibility, and data integrity.
• Collaborate with cross-functional teams to gather feedback and understand needs to identify valuable improvements that align with long-term goals, enhancing system functionality and elevating the overall user experience.
• Drive continuous improvement by proactively shaping CTMS strategies to align with evolving industry standards and regulations, ensuring sustained compliance and strong operational performance
• Monitor CTMS metrics, addressing performance, data quality, and usability issues in a timely manner.
• Provide and continuously improve CTMS training, support user community, and maintain resources like FAQs, CTMS Academy, and communication plans to support system adoption and updates.

Veeva Vault Implementation, Integration, & UAT:

• Collaborate with IT and vendor representatives to tailor the technology to meet unique business needs, streamlining technology use to support Regeneron’s processes.
• Lead the process of requirements gathering, liaising with key stakeholders to ensure clarity, comprehensiveness, and alignment with business needs.
• Refine the configuration and implementation of the Veeva Vault solution, ensuring its seamless alignment with Regeneron systems and strategies.
• Drive the adoption of Veeva Vault throughout the organization, integrating it with both current and anticipated business processes.
• Organize and supervise User Acceptance Testing (UAT), ensuring that implemented features align with gathered requirements and are free from critical issues. Partner with IT teams and vendors to rectify identified issues and refine system functionalities.
• Facilitate training sessions and workshops to optimize stakeholder familiarity and proficiency with the system.

Technology & Process Enhancement:

• Advocate for the introduction and integration of innovative technologies that bolster Regeneron's document management and communication operations.
• Maintain awareness of industry trends and best practices, positioning Regeneron as a frontrunner in technological applications in clinical operations.

Leadership & Team Collaboration:

• Lead and support CTMS related meetings including Superuser and Operational Working Group, 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

This role may be for you if you have:

• 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 i