Ronney Mathew

Clinical Research professional with experience in different therapeutic area well versed with trial monitoring, SAE report preparation, and SOP development. Currently leading monitoring at ImmunoACT Pvt Ltd, emphasizing timely reporting and trial optimization. Skilled in training, SOP development, and efficient data capture. Adept at stakeholder communication, regulatory compliance, and trial supply management.

Led Oncology trial monitoring, ensuring timely reports and optimizing trial efficiency.

 Conducting rigorous source document verification in line with the monitoring plan to maintain accurate, complete, and SOP-compliant trial records, minimizing any gaps.

 Managing and updating Trial Master File (TMF), including eTMF, to ensure alignment with the Site Master File. Maintaining a comprehensive record of essential documents and reports in collaboration with the Clinical Trial Assistant (CTA).

 Guided sites in SAE report preparation for IEC and Regulatory submission via SUGAM portal.

 Crafted and submitted Sponsor Serious Adverse Events (SAE) reports and CIOMS, emphasizing meticulous documentation and compliance.

 Conducted training for site personnel on trial protocols and operational procedures.

 Collaborating with the medical monitor, department head, and project manager to fulfill CSR appendices requirements and contribute to the finalization process.

 Developed SOPs for seamless translation of therapy procedures into commercial operations.

 Trained new recruits on SOPs and operational procedures, facilitating seamless integration.

Scheduled, planned, and conducted Site Selection Visits (SSV), Site Initiation Visits (SIV), Interim Monitoring Visits (IMV), and Site Close-out Visits (SCV)

 Prepared and reviewed site visit reports and Investigator Follow-up Letters, ensuring regulatory compliance and protocol adherence.

 Managed progress of assigned studies, including tracking regulatory/IRB submissions and approvals, recruitment, CRF completion, and data query resolution.

 Provided project updates to the project management team and organized delivery of investigational products and study materials.

 Performed investigational product inventory management, ensured proper return or destruction, and conducted site staff training on protocols and procedures.

 Collaborated with medical monitors and project managers for CSR appendices and SOP development.

 Maintained eTMF and ensured compliance with protocol and ICH GCP guidelines.