Senior Systems Analyst
BeiGene
**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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