Michel Shehata

About Michel Shehata

I am a seasoned Clinical Trial Manager with over 12 years of experience leading global…

Experience

1. Clinical Trial Manager

   Biorasi

   Aug 2024 — Present · US

   Clinical Trial Manager overseeing and supporting all clinical aspects of clinical trials on a global level, ensuring timely, high-quality deliverables. Collaborates with the Clinical Project Manager and cross-functional teams in preparing Requests for Proposal (RFP) and presenting in bid-defense meetings. During study start-up, assesses site feasibility, identifies execution/recruitment risks, and implements mitigations. Creates data-driven monitoring strategies to drive the integrity and quality of protocol’s endpoints data. Develops CRA boot-camp training, investigator meeting preparation, tracking/reporting specs, and. Contributes to study documents such as ICF, CRF design, and Study Management Plan.Creates Study Monitoring Plan, Protocol Deviation Plan, annotated reports, and PSV/SIV training material. Reviews clinical logs, forms, and guidelines. Manages site performance, reviews monitoring reports, analyzes protocol deviations, and guides CRAs on CAPAs. Builds investigator relationships and communicates updates.Oversees EDC data/query management to secure DBL within timelines. Manages TMF, coordinates IP and clinical supplies, and oversees IRT tracking. Reports to Director of Clinical Operations, escalates out-of-scope tasks, updates sponsors, and proposes solutions. Supports cross-functional teams and interacts with stakeholders.Coaches and guides clinical staff with tactical directions, monitors performance, and provides fair and constructive feedback. Ensures GCP, SOP, and protocol compliance, participates in quality assurance planning, and supports audit resolutions.

Education

• Misr University for Science and Technology

  Bachelor's Degree

  2001 — 2006

• Rutgers School of Health Professions

  Master's degree

  2023 — 2025