Senior Manager Business Operations
The primary responsibility of this role is to oversee the Clinical Trial Management System (CTMS) and optimize its capabilities for document management and process efficiency.
This includes ensuring the system's usability, efficiency, and alignment with business objectives are optimal. The CTMS serves as a crucial tool for managing clinical trial data, and it is essential to ensure its quality, completeness, and timeliness for study, country, and site operational data.
A key aspect of this role involves identifying interdependencies with other relevant CTMS modules/capabilities related to Study, Country, Site, and Person data capture and management to streamline clinical trial operations.
Additionally, this role entails creating and managing Control Documents and supporting materials to ensure business processes are repeatable, predictable, and scalable according to the volume of data managed in CTMS.
Collaboration with cross-functional teams is critical in gathering feedback and understanding needs to identify valuable improvements that align with long-term goals and enhance system functionality and user experience.
It is also essential to drive continuous improvement by proactively shaping CTMS strategies to align with evolving industry standards and regulations, ensuring sustained compliance and strong operational performance.
Metric monitoring and addressing performance, data quality, and usability issues in a timely manner are key responsibilities of this role.
Providing and continuously improving CTMS training, supporting the user community, and maintaining resources like FAQs, CTMS Academy, and communication plans to support system adoption and updates are also important tasks.
Veeva Vault Implementation, Integration, & UAT: collaboration with IT and vendor representatives to tailor the technology to meet unique business needs and streamline technology use to support processes is another key responsibility.
Leading the process of requirements gathering, liaising with key stakeholders to ensure clarity, comprehensiveness, and alignment with business needs is also a critical task.
Refining the configuration and implementation of the Veeva Vault solution to ensure seamless alignment with systems and strategies is also essential.
Driving the adoption of Veeva Vault throughout the organization and integrating it with both current and anticipated business processes is also a key responsibility.
Organizing and supervising User Acceptance Testing (UAT) to ensure implemented features align with gathered requirements and are free from critical issues is also a critical task.
Partnering with IT teams and vendors to rectify identified issues and refine system functionalities is also essential.
Facilitating training sessions and workshops to optimize stakeholder familiarity and proficiency with the system is also a key responsibility.
Advocating for introducing and integrating innovative technologies that bolster document management and communication operations is also an important task.
Maintaining awareness of industry trends and best practices, positioning the organization as a frontrunner in technological applications in clinical operations is also a key responsibility.
Leadership & Team Collaboration: leading and supporting 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.
Presenting to the Steering Committee and requesting endorsement of system enhancements, as needed, is also a key responsibility.
Managing, mentoring, training, and supporting other members of the team, as required, is also an important task.
Suitable candidates should have relevant experience in Clinical Trials, documents, and responsibilities internal and external to the Sponsor, along with familiarity with Veeva Vault Clinical modules and existing functionality.
Subject Matter Expertise in CTMS, TMF, and Organization/Person Profile Management is essential, as well as the ability to communicate complex issues to internal and external partners, drive effective decision-making, prioritize multiple important tasks, and maintain high-quality work.
Demonstrated adaptability to change, proven experience in a multi-disciplinary environment, Cross-functional Coordination Skills, Problem Solving / Decision-making, Risk Management Skills, Project Management, and People Management are desired qualities.