Mary H.

About Mary H.

Certified Clinical Research Professional (CCRP) with 6 years in the clinical research and development sector. Extensive experience in project management and trial management including creating detailed project plans, cross-functional collaboration, leading teams, stakeholder engagement, and risk management of global drug trials across Phases and several therapeutic areas, including rare disease, central nervous system, and oncology. Intimate understanding of ICH-GCP and FDA, Health Canada, and EMA regulations, as well as TMF, CTMS, and EDC systems. Fluent in English and Arabic, moderately proficient in Greek. Member, Society of Clinical Research Associates (SOCRA). BS, Microbiology and Cell Science from UF. Project Management Professional (PMP) Candidate.

Experience

1. Site Management Lead, Clinical Operations

   Veristat

   Mar 2022 — Present · Jacksonville, FL, US

   Identified a quality deficiency in the TMF Inspection-Readiness QC and spearheaded a corporate-wide process improvement initiative. Revised (SOPs) and delivered role-specific live training to all functional areas (100+ in attendance): clinical monitoring, project management, data management, etc. • Led the clinical operations of 5 global Phase clinical trials, including: successful activation, conduct and closeout of 30+ sites with no open issues. Oversaw site management personnel and activities including essential document preparation, patient recruitment, ICF revisions, IRB and regulatory review, and TMF transfer. Proactively identified risks and implemented mitigations to ensure smooth conduct in alignment with SOPs, ICH-GCP, and regulatory requirements of FDA, EMA, and Health Canada. Managed 4 projects at one time, including one decentralized and one high-complexity trial.• Held accountability as acting Project Manager for the overall delivery of a high-complexity global Phase I/II ultra-rare pediatric disease trial, overseeing all study functions and reporting trial progress, including impacts to time, quality, and cost to Sponsor representatives. Ensured project timelines and quality deliverables were met, serving as primary point of contact with the client. Perform vendor management and oversight (imaging, central labs, translations, travel services) and approved billable invoices. Successfully led the external Kick-Off meeting for the EU regional addition of 4 sites.• Contributed to the organization’s CTMS process improvement initiative, partnering with executive leaders to design system specifications, revise SOPs, complete UAT testing and serve as super-user, coaching and mentoring colleagues to ensure effective system adoption. • Successfully prepared for an cleared 3 study audits with no critical or major findings. • Coach and mentor over 25 site management personnel, including SMAs, CTAs, and CDSs.

Education

• University of Florida

  Bachelor of Science (B.S.)