Teams at Parexel

Conduct site management and monitoring activities from study initiation through closeout for oncology clinical trials. Ensure protocol compliance, data quality, regulatory readiness, site performance, recruitment progress, documentation, study supply accountability, and timely CTMS, EDC, and TMF updates. Build relationships with investigators and site staff, resolve issues, conduct site visits and training, support audits and inspections, and collaborate with study teams while working independently and traveling extensively.

Conduct clinical trial site management from qualification and initiation through closeout. Monitor site compliance, data integrity, recruitment, documentation, safety reporting, study supplies, payments, and regulatory readiness. Perform onsite and remote visits, resolve site issues, maintain CTMS and TMF records, support audits and inspections, and ensure adherence to ICH-GCP and local regulations. Work independently within a matrix team while communicating risks, timelines, and corrective actions.

Lead global CMC regulatory strategy for late-stage and marketed pharmaceutical products. Oversee IND, IMPD, BLA, MAA, and post-approval submissions; manage health authority interactions, manufacturing change assessments, reviewer responses, and regulatory correspondence. Coordinate cross-functional teams across R&D, manufacturing, quality, and clinical development. Provide strategic guidance to senior leadership, manage complex projects, mentor Regulatory CMC staff, and advance innovative regulatory approaches.