·        Maintain study and sponsor training matrices, trackers and training assignments across ICO Trial, Firecrest, DocuSign and Cornerstone LMS, supporting timely compliance across multiple studies.

·        Manage eTMF and study documentation to ICH-GCP, SOP and regulatory requirements; perform document QC, filing and reconciliation to strengthen audit and inspection readiness.

·        Generate compliance metrics and reports, investigate ODQA findings and system discrepancies, and coordinate corrective follow-up to protect documentation quality and data integrity.

·        Administer system access, onboard new associates and coordinate with sponsors, vendors and cross-functional teams to keep study activities and training deployment on track.

• Support process-improvement initiatives across clinical operations, using study systems and trackers to improve visibility, consistency and follow-through