Systems Designer / Analyst III

The Systems Designer / Analyst III will support the design and delivery of clinical trial systems within a data driven clinical development environment. The role will focus on technical study build, clinical data standards, system integration, and optimization of end user experience and data flow. The position will collaborate with cross functional teams to ensure program and study objectives are achieved on time and with high quality. The role will also contribute to process improvement, innovation, team development, and adherence to applicable clinical development standards and regulations., o Participates in the development and implementation of common clinical data standards while ensuring system designs align with protocol requirements and established standards. o Establishes and maintains methodologies for designing and developing clinical trial systems while benchmarking practices against applicable industry standards. o Ensures clinical systems are designed to optimize functionality, end user experience, data flow, and consistency across therapeutic area and program level activities. o Leads the timely design and delivery of new clinical systems, system integrations, and required modifications to existing clinical trial technologies including EDC, IRT, and ePRO platforms. o Uses project management tools to monitor study progress, plan activities, identify potential timeline or quality risks, and develop appropriate solutions. o Collaborates with clinical data organization members and cross functional stakeholders to align deliverables with upstream and downstream dependencies. o Ensures compliance with federal and applicable local regulations, Good Clinical Practices, ICH Guidelines, standard operating procedures, and functional quality standards. o Provides coaching and mentoring to team members and contributes to their professional and technical skill development. o Leads innovation and process improvement initiatives across clinical data and cross functional teams.

o Bachelor’s degree in business, management information systems, computer science, life sciences, or an equivalent field. o 7 or more years of hands on technical clinical study build experience in EDC. o Required hands on technical study build experience using Medidata RAVE. o In depth knowledge of clinical trial processes. o In depth knowledge of CDASH and SDTM. o Demonstrated ability to contribute to organizational initiatives and continuous improvement activities. o Demonstrated ability to influence stakeholders without direct authority and work effectively within a matrix environment. o Strong coaching, mentoring, communication, analytical, and problem solving skills. Preferred Qualifications: o Master’s degree in a relevant field. o Hands on technical study build experience using Veeva EDC.

o Experience with clinical system integration and implementation across multiple clinical trial technologies. o Experience leading innovation and process improvement initiatives. Benefits: The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually - AS Applicable).

Job Requirement o Medidata RAVE o EDC Study Build o Clinical Trial Processes o CDASH o SDTM o Clinical Data Systems o Clinical Systems Integration

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