Associate Director, Clinical Systems Implementations

Associate Director, Clinical Systems Implementation manages activities related to the successful validation, implementation, and use of multiple small to medium size/complexity applications or large/highly complex application or a platform. The role effectively and efficiently engages stakeholders both internal and external, working with leaders throughout the business in Research & Development, Information Technology, Quality, and Regulatory in pursuit of clear and accurate enablement of digital and emerging technologies and innovation. The role represents business users in application related discussions related to the design, development, and deployment of the application to support business process, and works in close collaboration with our Research & Development division-IT. The role ensures compliance to company policies, agency regulations and related guidance around technology and applies data stewardship and data governance principles in the management of the application.

Serve as a Subject Matter Expert (SME) on the use of the application and lead completion of various System Development Life Cycle (SDLC) activities. Lead collection, tracking and prioritization of requests from users requiring modifications (upgrades or bug fixes) to existing systems. Partner with various business functional stakeholders and our Research & Development division-IT to support creation of high-impact & high-value business cases for innovation opportunities and advance selected solutions from proof of concept to pilot and implementation at scale, ensuring required due diligence has been carried out, and the solution is audit/inspection ready, if applicable. Represent the business during discussions with the system vendor and Technical Lead as the primary contact and to ensure right business needs and enhancements are proposed & evaluated for feasibility. Collaborate with user experience experts and collect early and ongoing feedback from users to ensure solution being developed will provide optimum user experience once enabled. Partner with the Technical Lead & Business Analyst to document and approve requirements that have appropriate criticality assigned, are testable and will enable the desired functionality to support the business process. As applicable, work with business users to identify study specific changes needed to the application and integration to connected systems; enable these changes with the help of our Research & Development division-IT, vendor, system owners of connected systems. Identify and manage the Key Performance Indicators (KPIs) to measure outcomes and success of technology solutions being implemented to improve clinical operations productivity and site and patient experiences. Approve change requests for upgrades/bug fixes/data changes and coordinate release planning and assessment for the business in collaboration with IT. Work with solution provider to ensure appropriate enhancements are incorporated in vendor roadmap that not only supports current process/needs but also future vision and innovative technology options. Establish a baseline for customer satisfaction, monitor customer satisfaction regularly through forums and surveys, and leverage the insights gained from customer feedback to refine the roadmap. Create appropriate training materials (training manuals/e-learnings/Job Aids) and process documentation (Standard Operating Procedures (SOP's)/Guidelines) to support the use of the system. Periodically assess and update if needed. Facilitate trainings to ensure users are appropriately trained in the use of the system. Communicate system functionality changes and impact to existing processes to the users in a concise and timely manner. Perform business process impact assessments for new applications or enhancements to existing application and provide details to Business Process/Sub-process Owners to make necessary updates to the processes. Contribute to the ongoing