Emeryville, CA, 94662, USA
1 day ago
Senior Systems Analyst
**General Description:** + The Senior Systems Analyst role will be responsible for configuration, administration and maintenance of business-critical Clinical IT systems and applications. + The ideal candidate should bring experience working on multiple projects across different functions for a global, geographically diverse environment. + The candidate should be experienced implementing Clinical Systems from end-to-end, including supporting/troubleshooting business critical integrations. + The individual must be able to provide technical expertise and have extensive application administration experience, especially clinical systems with integrations. + The candidate should have strong understanding of Computer Systems Validation and SDLC methodologies in GxP regulated environment. + This role requires ensuring the operational activities for the system are in adherence to policies and procedures. **Essential Functions of the job:** + Support the prioritization of projects, changes and operational activities as defined by GTS management. + To provide clinical trial systems implementation, operational and maintenance support under the guidance of senior staff. Clinical systems mentioned here refer to systems that support clinical operations. + Collaborate with project team members in the testing and validation of changes and enhancements to the system including: + Participate in functional requirement gathering and design review meetings. + Work with the business to develop system requirements. + Oversee documentation of configuration and design specifications. + Manage and sometimes execute User Acceptance Test (UAT) scripts. + Oversee the authoring of computerized system validation documentation. + Perform regular operational activities in support of help desk tickets specific to systems issues and questions from end users including but not limited to: + User Account creation/modification + Integration problem and investigation + Report analysis and customized report generation + System bug escalation, etc. + Synthesizes data, information, and knowledge to clarify system issues or problems. + Implements processes that streamline reporting within clinical systems. + Develop support related documents as needed. + Where applicable, deliver system related IT training to end users and/or form the training process in compliance with GCP. + Completes other special tasks or projects, as and when assigned, or otherwise requested. + Consistently complies with all governing laws, regulations, company SOPs and other guidelines. **Education Required:** Bachelor’s degree required **Supervisory Responsibilities:** + N/A **Experience Requirements::** + Prior experience working in the Biotech/Life Sciences or IT Consulting industry, including pharmaceutical, biotechnology or medical device. + Minimum (4) years direct experience operating in a systems analyst role with a proven record of business analysis including development of requirements and mapping business processes to technical solutions. + Able to 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. + End-to-end hands-on experience implementing clinical systems. + Extensive experience gathering and documenting end user requirements and translating to technical requirements. + Excellent organizational, interpersonal and customer service skills; excellent communicator with active-listening skills. + Able to analyze, clearly document and communicate user requirements. + Hands-on experience administering SaaS/Cloud platforms. + Able to work in a global IT delivery service model. + Experience working in a team-oriented, collaborative environment. + Proven experience operating in regulated environments, with GxP and 21 CFR Part 11. + Understands software delivery lifecycle and computer systems validation. **Other Qualifications:** + Knowledge and experience of clinical trial processes. + Previous experience in development, deployment and/or maintenance of clinical systems in the pharmaceutical, biotechnology or related industry is a big plus. + Knowledge of international regulations, processes and issues in drug development. + Familiarity of clinical operations processes is an advantage. + Fluent English and/or other language skills as needed. + Outstanding attention-to-detail and follow through. + Comfortable working in a fast-paced, dynamic environment, and adapt to changes in responsibilities and workloads. + Excellent time management & organizational skills: can prioritize multiple tasks and goals and ensure the timely, on-target accomplishment with precision. + Good interpersonal, communication skills. + Works well within teams and is effective in collaborating with others internally and externally. **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.
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