Clinical Documentation and Process Specialist

The Staff Specialist, Clinical Development Functional Excellence works in direct partnership with Clinical Development study teams and closely with key stakeholders in Quality, Regulatory Affairs, IT/Software, Legal and other functions to maintain the eTMF and other clinical systems, optimize Clinical Development processes to enhance efficiency, track compliance and training activities, develop and report KPIs/metrics, and ensure audit readiness. You will report to the Vice President, Clinical Development. May require occasional travel to clinical sites or vendor locations. Responsibilities include serving as primary administrator for Clinical Development’s eTMF system, developing and implementing eTMF workflows, overseeing training activities, tracking and reporting KPIs, leading the development of standardized processes, and partnering with Clinical Quality Assurance to ensure GCP compliance.