RegionalClinicalTrialManagementAssociate

## Accountabilities Support regional and country-level clinical trial execution, ensuring alignment with study timelines, quality standards, and operational requirements. Assist Clinical Research Associates and Study Start-Up Specialists in day-to-day clinical study activities, including site communication and documentation tracking. Contribute to study start-up processes, including feasibility support, regulatory documentation, and site activation activities. Maintain and update essential clinical trial systems such as CTMS, eTMF, and SharePoint repositories. Support monitoring preparation activities, site coordination, and follow-up on study deliverables and queries. Assist in organizing study meetings, investigator meetings, and cross-functional coordination sessions. Support quality assurance activities, including TMF maintenance, document reconciliation, and compliance checks. Contribute to budget and operational support tasks, including vendor setup and payment tracking. Help identify operational risks and contribute to continuous process improvement initiatives. Requirements: Bachelor’s degree in a scientific or healthcare-related field (preferred). Minimum of 2 years of experience in clinical trials or clinical research operations (site, CRO, or pharmaceutical industry). Solid understanding of clinical trial processes, ICH-GCP guidelines, and clinical operations workflows. Experience with clinical systems such as CTMS, eTMF, and MS Office tools. Strong organizational skills and ability to manage multiple operational tasks simultaneously. Excellent communication and collaboration skills to work effectively with cross-functional and regional teams. High attention to detail with a strong focus on compliance and quality standards. Fluent English is required; Spanish is considered a plus. Ability to work in a structured, fast-paced, and regulated environment. Benefits: Competitive compensation package Health and medical coverage options Remote or hybrid work flex