Teams at Venesco, LLC

Perform site qualification, initiation, monitoring, and closeout visits; conduct source data verification, review informed consent and regulatory binders, evaluate protocol compliance, generate monitoring reports, support site training, CAPA tracking, audit/inspection readiness, and maintain study documentation.

Lead and oversee FDA-regulated clinical studies across startup, conduct, and closeout. Manage project plans, TMF, protocol documentation, stakeholder coordination, ClinicalTrials.gov reporting, study metrics, risk mitigation, and support inspections and audits.

Support CMC, quality, manufacturing, and nonclinical activities across product lifecycle: review specs, validations, stability, audits, regulatory CMC content, manufacturing risks, and logistics.