Teams at Parexel

Manages clinical trials from initiation through closeout, overseeing vendors, CROs, monitoring activities, study documentation, site compliance, patient enrollment, investigator meetings, data queries, supplies, contracts, and trial master file maintenance. Ensures adherence to protocols, SOPs, GCP, FDA requirements, and ICH guidelines while coordinating cross-functional stakeholders and resolving execution issues.

Lead and support site start-up through close-out: compile Investigator Initiation Packages, coordinate regulatory and ethics submissions, manage site activation timelines and clinical trial systems, resolve site issues, and collaborate with regulatory and country teams to ensure ICH/GCP and local compliance.

Manages clinical trial investigator sites from activation through close-out, ensuring patient safety, GCP compliance, protocol adherence, data quality, and timely study execution. Responsibilities include onsite and remote monitoring, site relationship management, investigator and staff training, recruitment support, adverse event follow-up, investigational product oversight, issue resolution, CAPA remediation, documentation, audit support, and database release activities. Requires extensive clinical research monitoring experience and frequent travel.