**General Description:** The GTS (Global Technology Solutions) Manager of Clinical Systems is responsible for design, development, implementation, and administration of critical Clinical Business Systems for the Global Patient Safety (GPS) organization. The role will work closely with the GPS team, to define and document functional and technical requirements for both validated/non-validated Clinical Systems, system integrations, dashboards/reports, as well as identify and implement solutions to address areas of improvement within systems. This role will also be responsible for operational support of Clinical Systems and requires hands-on experience building and/or configuring systems and requires close collaboration with teams of GTS technical application owners, network/security engineers, and GTS infrastructure. The ideal candidate should bring experience working in GxP environment with the ability to manage multiple projects across different functions for a global, geographically diverse environment. The candidate should also be experienced at supporting GTS projects from a business analysis, technology, security, process, and people management standpoint. **Essential Functions of the job:** + Act as technical and/or project lead in the planning, design, configuration, testing and deployment of new systems and enhancements to existing computerized systems primarily for the Global Patient Safety (GPS) team. + Ensure the overall health and stability of deployed applications and coordinate resolution when issues arise. + Deliver on multiple projects and tasks independently, quickly learn new technologies and systems, and think critically about system impact to GPS business processes and global end user adoption. **Strategy & Planning** + Collaborate with GTS Infrastructure Engineering, Validation Engineers, Operations, Security/Compliance, QA, Service Desk and applicable vendor teams to properly assess system complexity, compliance requirements and technical requirements + Partner with stakeholders in the design, configuration and data integration between multiple systems along with future strategy towards an integrated clinical platform + Solution systems for the purpose of enhancing business processes, operations, and information flow across the Clinical Operations organization. Provide solution options to all levels of management with the ability to recommend industry and best practices and implement accordingly **Implementation and Delivery** + Collaborate with project teams in the planning, design, configuration, and deployment of new applications, and enhancements to existing applications and platforms. + Represent GTS as the application owner and/or technical lead for projects and enhancements from initiation through implementation and support. + Facilitate technical support during application implementation, upgrades and migrations. + Liaise with computer system vendors, GTS partners, Quality, Validation and the business to coordinate implementation activities. + Partner with GTS Help Desk and GTS Operations to develop post-implementation support structure. + Author system process documents such as SOPs/Work Instructions, User Access forms, runbooks + Gather and document end user requirements and translate to technical requirements. + Support multiple projects and manage tasks independently, quickly learn new technologies and systems, and think critically about global business processes and global end user adoption. + Manage consultants/vendors to ensure projects and/or required system administration activities are addressed adequately. **Operational Management** + Adhere to global GTS security policies and follow proper GTS Change Control processes, including remediation of systems that are out of compliance to GTS policies and best practices. + Oversee change management for existing systems adhering to GxP processes. + Support GxP activities on existing systems including user access review, periodic review, etc + Monitor/triage help desk tickets and escalations as related to Clinical Systems. + Support audit and inspection requests. + Provide administration support, manage access and security, and provide recommendations for reported issues/enhancement requests from end-users. Occasionally provide end user training. Test any fixes and perform post-resolution follow-ups to ensure issues have been adequately addressed. + Work with software vendors to understand existing and future release functionality including execution of protocols, perform testing sequences and change controls. **Supervisory Responsibilities:** + This position may include managing vendors, contractors. This position may also include managing staff; coaching and mentoring of junior staff with training/orientation/qualification and development plan when required. **Qualifications** + 5+ years of Biotech/Pharmaceutical industry experience with comprehensive management of clinical technologies and platforms (i.e.,Argus, PPD, Evidex, Veeva, PowerBI, etc.) + Direct experience operating in a business/technical analyst role with a proven record of business analysis including development of requirements and mapping requirements to data/technical solutions + Direct hands-on experience supporting and administering GxP computerized systems within an SDLC framework. + Proven experience in overseeing the direction, planning, installation, implementation, validation, and maintenance of software solutions **Education Required:** Four-year college diploma or university degree in Life Science, Computer Science, Information Systems or equivalent experience. **Other Qualifications:** + Excellent project management skills and/or substantial exposure to project-based work structures. + Ability to communicate ideas in both technical and user-friendly language. + Ability to effectively prioritize and execute tasks in a team-oriented, collaborative environment. + Strong knowledge of authoring computer system validation documentation, SOPs/Wis and runbooks + Ability to take independent action, working with a high-level problem or concept, developing the right next steps to propose resolution and ensuring successful outcome. + Balance creativity and innovation against practical /cost effective approaches. + Strong process improvement skills and orientation + Excellent organizational, interpersonal and customer service skills; excellent communicator with active-listening skills. Strong commitment to customer service and proactively follows up with end users. **Travel:** < 5% All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.