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Senior Application Analyst
4 days ago
**Hard Skills**
- Bachelors degree in computer science, statistics, biostatistics, mathematics, biology, or other health-related field or equivalent experience that provides the skills and knowledge necessary to perform the job.
- 5+ years of life sciences industry experience and knowledge of clinical trial processes.
- 2+ years experience in end-to-end data management-related activities (database design, data collection, data analysis, query resolution, datasets, statistical reporting).
- 2+ years experience working with EDC clinical software solutions in clinical operations and/or trial management.
- Experience in interpreting clinical protocols.
- Experience with unstructured data processing and transformation.
- Experience maintaining data pipelines for large amounts of data efficiently.
- Working understanding of data management standards and guidelines (CDISC (ODM, CDASH, SDTM)).
- Knowledge of XML, JSON, APIs, Python.
- Understanding of current GCP, ICH, and FDA guidelines and regulations applicable to the conduct of clinical research.
- Good operational knowledge of mobile diPadsevices, such as iPad.
**Soft Skills**
- **Exceptional written and oral communication skills in the English and Japanese languages are required.**:
- Ability to work creatively and independently to carry out assignments of a complex nature.
- Ability to work as a member of a multi-national team and the willingness to occasionally participate in off-hours meetings.
- Proven ability to work independently in a dynamic, fast-moving environment but also as part of a team.
- Strong attention to detail and outstanding organizational skills.
- Exceptional interpersonal skills, focusing on rapport-building, listening, and questioning skills.
- Ability to absorb and retain information quickly.
- Highly self-motivated and directed.
- Proven analytical and problem-solving abilities.
- Ability to effectively prioritize and execute tasks in a high-pressure environment.
- Friendly to customers, enjoy the interactions and helping others.
**Responsibilities**
- Help the sites for any technical issues related to software installation, log in, operation, etc. or questions cannot be resolved, log into the helpdesk system (ideally in English) and help with the communication between our team and the sites.
- Participation in on-call coverage.
- Partner closely with internal/external stakeholders in a collaborative manner.
- Assist with the development and maintenance of departmental and divisional work best practices, SOPs, forms, and templates.
**Support**:
- Troubleshoot system issues and, if unable to resolve, escalate accordingly.
- Develop expertise in data integrations with key data providers used by customers.
- Provide guidance on system configurations, capabilities, and system behaviors.
- Provide oversight, technical support, and guidance to the customer study teams in the efficient use of our platform for data management activities throughout the execution of clinical studies.
- Contribute to knowledge base articles, support and configuration Q&A, and training materials.
- Execute post-deployment smoke testing as required.
**Configuration Services**:
- Work with customers to review and understand clinical protocol requirements.
- Work with the Support Manager and Project Manager to coordinate and align on configuration tasks.
- Collaborate with various vendors and cross-functional teams, as required, to build and/or align on data transfer specifications and ensure a streamlined process of data integration.
- Configure data extraction (i.e., data providers) across multiple study-level data sources.
- Configure source and review data standards.
- Configure mappings and transformation of raw data from source to review data models.
- Configure validation rules (edit checks).
- Configure data visualization tools for use by various clinical data reviewer roles (e.g., Data Managers, Medical Monitors, etc.).
- Contribute business and technical expertise on various aspects of clinical data flows.
- Perform peer review study configuration quality checks.
- Assist customers as they test configurations.
- Review and provide feedback on the system integration strategy, optimization of integration services, and recommendations to product and integration teams for improvements
**Work Conditions**
- 40 hours per week, 8 hours per day (Monday-Friday).
- Full-time, remote (home-based), long-term.
- The working schedule is by EST time zone.
**PTO and Vacations**:
- 1.5 PTO per full-time month worked.
- Total PTO days per year: 18.
- 2 Paid time off for state holidays per quarter.
- Total state holidays per year: 8.
**Salary**: ฿120,000.00 - ฿151,000.00 per month
**Education**:
- GCSE or equivalent (preferred)
**Experience**:
- Technical support: 3 years (preferred)
- Customer service: 3 years (preferred)
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