Senior Manager SSU Business Services

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 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.

In order to be considered qualified for this role , a minimum of a bachelor’s degree with 8+ years relevant experience is required.

• Risk Management Skills - evaluating risks based on sound business analyses is required.
• Project Management - ability to take a leadership role in managing projects is preferred.
• People Management – ability to lead a team of direct reports is preferred

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)