Clinical Systems Implementation Leader

Merck; North Wales (Montgomery County); On-site; USD 180,000 - 240,000; Full time

Job summary

Merck is seeking an Associate Director, Clinical Systems Implementation to lead validation, implementation and ongoing use of multiple applications within clinical operations. You will collaborate with Research & Development IT, Quality, and Regulatory teams to enable digital technologies and ensure audit readiness.

As SME, you will manage SDLC activities, prioritize change requests, coordinate with vendors, document requirements and train users, driving improvements in patient care and

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.

Job description

Merck is seeking an Associate Director, Clinical Systems Implementation to lead validation, implementation and ongoing use of multiple applications within clinical operations. You will collaborate with Research & Development IT, Quality, and Regulatory teams to enable digital technologies and ensure audit readiness.

As SME, you will manage SDLC activities, prioritize change requests, coordinate with vendors, document requirements and train users, driving improvements in patient care and