Associate Director, Clinical Systems Implementations

Job description

Job Description 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. Responsibilities: 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 development of global standardized procedures for the use and maintenance of the application across functional groups and countries. Monitor support metrics and performance of the system on routine basis to assess needs for improvements (added resources or technology improvements). Work with business to ensure optimized use of product features. Partner with the IT Support Lead to coordinate downtime communications – content, timing, contacts, etc. Work with IT and support team to create user provisioning and deprovisioning process. Periodically audit user access to system to ensure only intended users have access. Manage User Acceptance Testing (UAT) related activities such as assessing UAT needs, developing high-level UAT plans, identifying testers for UAT, drafting test scripts, setting up data to support testing, conduct dry run of test scripts, make needed updates, perform testing, track issues during testing and ensure proper SDLC documentation is completed prior to deployment. Ensure proper process and guidelines are in place to share and exchange data between applications & apply record retention policy. Act as primary business contact for assigned systems during audits and inspections and collaborate with IT and process owners to respond to all audit and inspection related requests in a timely manner. Experience & Skills: Bachelor's degree or higher with 5+ years of experience in Science, Clinical Research, Computer Science, or similar fields At least five years of experience in technology implementation, business process improvement, project management, systems analysis or systems maintenance/support Broad understanding of drug development -safety, clinical trials, trial design, data management, trial operations, regulatory, privacy, International Council for Harmonisation (ICH), and Good Clinical Practice (GCP) required. Ability to quickly gain thorough understanding and become subject matter expert in a new business area as needed, e.g. Risk Based Monitoring, Structured Content Authoring, clinical content standards. Strong verbal & written communication skills - able to present information confidentially and effectively to leadership, peers, and team. Ability to proficiently interact with all levels of management, exert influence to achieve results without authority and successfully manage senior/Executive level stakeholders. Project management experience is a plus. Deep knowledge and understanding of Clinical Trial processes as well as quality management and control tools. Experience with critical clinical systems such as Clinical Trial Management Systems (CTMS), electronic Trial Master File (eTMF), Electronic Data Capture (EDC) system, clinical portal and basic reporting and MS Office tools. Understanding metrics and being able to identify trends. Fluency with the respective cross-functional interdependencies, roles and enabling tools/technologies. Able to identify critical input and outputs that drive business processes and dependencies on process (workflow) vs. technology (dataflow). Exposure to a global environment, with multi-cultural and organizational operating models; appreciation for country requirements/needs vs. US standards. Requires management and leadership skills, analytical ability, good judgment, ability to multi-task, conflict resolution expertise and discretion. Customer service orientation and the ability to work effectively with clients, third party vendors, quality and IT management/staff. Experience in training user community. Experience in Risk Based Quality Management (RBQM) (Critical to Quality (CtQ), Key Risk Indicators (KRI), Quality Tolerance Limits (QTL), etc.) clinicaltrialjobs Required Skills: Adaptability, Clinical Data Management, Clinical Research, Cross-Functional Teamwork, Decision Making, Good Clinical Practice (GCP), Quality Management, Risk Management, Strategic Planning, Strategic Thinking Preferred Skills: Clinical Systems, Clinical Trial Management, Pro