Manager, TMF Systems

📋 Description

• • As a Manager, TMF Systems at BeiGene, Ltd., you will play a pivotal role in managing and optimizing the Trial Master File (TMF) processes and the global eTMF system. This position is crucial for ensuring the integrity, compliance, and efficiency of our clinical trial documentation, directly contributing to BeiGene's mission of fighting cancer.
• • You will collaborate closely with your supervisor to execute multiple, highly complex TMF processes, aligning with the global eTMF system and the overarching Global TMF roadmap. This involves understanding the intricate details of TMF management and applying them to a global context.
• • A key responsibility will be managing the validation of the eTMF system. This includes overseeing change controls, data migration activities, and system integrations to ensure the system remains robust, accurate, and compliant with regulatory standards.
• • You will be responsible for the operational aspects of the eTMF system, including the efficient handling of support tickets and the management of user access requests, ensuring that study teams and other stakeholders have the necessary access and support to perform their roles effectively.
• • This role requires a proactive approach to process improvement. You will be tasked with creating new processes using various tools to enhance both the eTMF system's functionality and overall business processes, driving efficiency and effectiveness.
• • You will assist in the creation and maintenance of essential eTMF reports and dashboards, providing critical insights into TMF status, compliance, and performance metrics as required by management and study teams.
• • Utilizing eTMF tools, dashboards, and associated technology, you will analyze TMF metrics. This analysis will be used to communicate actionable insights and requirements to study teams, peers, and system end-users, fostering a data-driven approach to TMF management.
• • Effective communication and active collaboration are paramount. You will engage with managers and leaders across the organization to discuss TMF processes, the eTMF system's performance, and to address pending inquiries, ensuring alignment and transparency.
• • You will be responsible for analyzing and reporting on key metrics as required, providing clear and concise data that supports decision-making and strategic planning related to TMF operations.
• • Participation in department meetings and end-user forums is expected. This engagement will help you develop a deeper understanding of system tools and their application, enabling you to contribute to the continuous improvement of business processes.
• • A core expectation of this role is the ability to accomplish tasks with a strong focus on data integrity and quality, operating independently and without direct supervision, ensuring the highest standards are maintained.
• • You will assist in and potentially lead data migrations/transfers and integrations, working collaboratively with IT and other internal and external stakeholders to ensure seamless transitions and data accuracy.
• • Support will be provided for User Acceptance Testing (UAT) processes and documentation, contributing to the thorough vetting of system changes and enhancements.
• • You will lead activities focused on improving the eTMF dashboard and metrics, ensuring that reporting is accurate, insightful, and aligned with business needs.
• • In terms of supervisory responsibilities, you will manage projects, ensuring that resources allocated to projects and tasks deliver results on time and within scope.
• • You may also be required to manage contractor resources and system analysts, providing guidance and oversight to ensure project success.
• • This role demands a strong understanding of TMF regulations and best practices within the pharmaceutical industry, ensuring all activities are compliant and support regulatory inspections.
• • You will be a key point of contact for eTMF system-related queries and issues, providing timely and effective resolutions.
• • The ability to influence cross-functional teams and stakeholders to adopt best practices and drive process improvements will be essential for success in this role.
• • You will contribute to the development and implementation of TMF SOPs and Work Instructions, ensuring clear guidelines for all TMF-related activities.
• • Proactively identify potential risks and challenges related to TMF management and system operations, and develop mitigation strategies.
• • Stay abreast of industry trends and technological advancements in TMF management and clinical systems, recommending innovative solutions to enhance BeiGene's capabilities.
• • Ensure that all TMF documentation is organized, complete, and readily available for audits and regulatory inspections.
• • Foster a culture of continuous improvement within the TMF systems team, encouraging knowledge sharing and professional development.
• • The role requires a strategic mindset, balancing day-to-day operational needs with long-term system and process development goals.
• • You will be instrumental in ensuring that BeiGene's TMF operations are best-in-class, supporting the efficient and compliant execution of clinical trials worldwide.
• • This position offers a unique opportunity to make a significant impact on global clinical operations and contribute directly to bringing life-saving medicines to patients.