Mary Anne Ramos Iniego

Offshore Compliance Specialist II

Alliance Clinical Network

Oct 2023 - Apr 2025 (1 year 7 months)

• Managed end-to-end data validation and query verification assuring clinical data integrity and alignment with study protocols. • Resolve and document quality discrepancies promptly by tracking data trends and implementing target CAPA. • Audited clinical trial data and documentation to maintain strict compliance with FDA, GCP and ICH standards. • Drive cross-functional initiatives to build and standardize clinical SOPs, improving process clarity and audit readiness.

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Clinical Research Associate

World Health Organization (WHO) - Solidarity Trial Vaccine Pi Health Inc (PIVOT)

Oct 2021 - Jun 2023 (1 year 9 months)

• Facilitates the conduct of trials assuring the quality of study in accordance to data monitoring. • Maintained a hybrid work schedule, balancing onsite visits and remote data review. • Independently manage to do monitoring activities for multiple site, identifying SOPS and deviations. • Evaluated clinical protocol and regulatory compliance including source data verification, informed consent process, human subject protection, drug accountability, data integrity and review of Investigator and Regulatory Files. • Initiate and provides guidance to designated site personnel conducting the study in line with protocol, trial specific procedures, SOPS and applicable regulations. • Documents routine site management such as follow-up, clinical mon

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Case Management Specialist

ISTA Personnel Solutions

Apr 2021 - Aug 2021 (5 months)

• Monitored personalize care plans leveraging proactive goal-setting to maximize client engagement and achieve key care objectives. • Evaluated patient progress by adapting care strategies to meet evolving physiological and psychological needs and monitored the efficacy of implemented interventions. • Connect patients with appropriate services in collaboration with healthcare providers and care coordinators.

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Prior Authorization Technician

Optum - Teletech

Oct 2019 - Jun 2020 (9 months)

• Review and approve physician inquiries for pre-authorization of medicine. • Provide direct support to clients enrolled in pharmacy benefits guiding them through coverage processes, clarifying plan details and assisting with prior authorizations ensuring timely access of medications. • Transcribe medical reports and claims.

Mary Anne Ramos Iniego

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