Soundarya Lakshmi

Clinical Trial Operations & Study Start-Up (Belgium-Based / EU-Focused)

Comprehensive expertise in managing end-to-end clinical trial operations across Belgium and multi-country European settings, ensuring compliance with EU regulatory frameworks and ICH-GCP standards.

Study Start-Up & Regulatory Coordination: Lead feasibility assessments, site selection, ethics submissions, and regulatory approvals within Malta and across international jurisdictions, ensuring timely study activation.

Monitoring & Site Management: Oversee on-site and remote monitoring activities, maintaining protocol adherence, data integrity, and audit readiness. Build strong relationships with investigative sites to optimize performance and enrollment.

Site Initiation & Training: Conduct site initiation visits (SIVs), ensuring investigators and site staff are fully trained on protocols, systems, and compliance requirements.

Global & Multi-Country Study Coordination: Coordinate cross-functional teams and vendors across multiple countries, aligning timelines, deliverables, and communication for seamless study execution.

Risk Identification & Mitigation: Proactively identify operational and clinical risks; implement mitigation strategies to ensure patient safety, data quality, and study continuity.

Data Annotation & Clinical Data Management: Support accurate data capture, annotation, and validation processes, ensuring high-quality datasets ready for analysis and regulatory submission.

Quality Control & Compliance: Maintain rigorous quality control processes, ensuring adherence to SOPs, regulatory guidelines, and inspection readiness at all stages of the trial lifecycle.

Strong understanding of Belgium’s clinical research environment, including collaboration with local health authorities, ethics committees, and healthcare institutions, while leveraging its strategic position within the EU for efficient multi-country trial execution