Clinical Data Systems - Study Build Lead

o This role provides technical leadership for the design, development, and delivery of clinical trial systems and data standards. o The position supports study level and program level activities across clinical development programs. o The role ensures clinical systems meet protocol requirements, data standards, regulatory expectations, quality standards, and end user needs. o The successful candidate will coordinate technical study build activities, system integrations, timelines, dependencies, and quality requirements. o This position also contributes to process improvement, innovation, coaching, mentoring, and organizational development initiatives., o Lead technical study build activities within electronic data capture clinical trial systems. o Design and develop clinical trial systems based on protocol requirements, clinical data standards, and established methodologies. o Ensure clinical system designs follow applicable standards and support effective functionality, user experience, and data flow. o Coordinate the delivery of new clinical systems, system integrations, and required system changes. o Use project management tools to monitor study progress, timelines, dependencies, risks, issues, and deliverables. o Identify issues that may affect study timelines or quality and develop appropriate solutions. o Collaborate with Clinical Data Operations and cross functional teams to achieve program and study objectives. o Ensure assigned work products are aligned with upstream and downstream dependencies. o Support consistency across therapeutic areas and clinical development programs. o Ensure adherence to Good Clinical Practice, International Council for Harmonisation guidelines, applicable regulations, standard operating procedures, and quality standards. o Stay current with evolving regulations, guidelines, and policies related to clinical development. o Contribute to the development and continuous improvement of clinical system design methodologies. o Coach and mentor team members and support their technical skill development. o Lead or contribute to innovation and process improvement initiatives.

o Bachelor’s degree in Business, Management Information Systems, Computer Science, Life Sciences, or equivalent experience. o Seven or more years of hands on technical study build experience in electronic data capture systems. o Required hands on technical study build experience with Medidata Rave. o In depth knowledge of clinical trial processes. o Required in depth knowledge of Clinical Data Acquisition Standards Harmonization. o Strong knowledge of Study Data Tabulation Model. o Experience with clinical trial system design, configuration, delivery, and integration. o Demonstrated ability to influence stakeholders without direct authority. o Experience working effectively in a matrixed environment. o Strong communication, analytical, problem solving, and organizational skills. Preferred Qualifications: o Master’s degree. o Technical study build experience with Veeva EDC. o Experience with Interactive Response Technology systems. o Experience with electronic Patient Reported Outcomes systems.

o Experience with clinical system integrations. o Experience leading clinical data technology or 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 Technical Study Build o Clinical Data Management o CDASH o SDTM o Clinical Trial Systems

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