Monica Huke

S and S Consulting is an independent company which provides contract services for Phase I-III and post-consumer marketing studies. Contracted services include but are not limited to: *Hiring oversight, management and development of cross-functional teams including Study Start-up Specialists (SSU), CRAs, Project Managers and Directors. *Responsible for the start-up, implementation and rollout of electronic systems of records for Clinical Trial Management Systems (CTMS) and Electronic Trial Master File (eTMFs), including training and serving as the Subject Matter Expert (SME). *Serve in an advisory roll for device studies where pharmaceutical/medicinal product input is required for study conduct, including IRB/IEC submissions and country-specific requirements, as applicable. *Responsible for completion of GAP Analysis for SOPs and guidelines and assessment of compliance for existing SOPs toward the requirements of ICH/GCP. June 2023 - Present Veranex, Inc. Sr. Director of Clinical Pharma - CRO and Consulting Services (CROCS) - North America *Responsible for the direct oversight of ClinPharm staff and all pharmaceutical research projects where clinical operations is included in scope. Participate in the day-to-day activities from study start-up through close-out, including monitoring as needed. *Responsible for the project management for initiation, implementation and roll-out of software solutions for CTMS and eTMF (Veeva), including providing any supplemental training and serve as the Vault Owner and Administrator. *Serve on the Global CROCS Leadership Team and contribute to the operational strategies, policies and initiatives, which contribute to global growth and efficiency. February 2021 - May 2023 Hansen Research Consulting Director of Clinical Trial Monitoring Services (CTMS) - Midwest Responsible for the complete oversight of study start-up activities, regulatory document management and TMF compliance.