Summary
Overview
Work History
Education
Skills
Education And Certifications
Timeline
Generic

WIJDAN SULIMAN

Rosedale

Summary

Results-driven Clinical Research Professional with 10+ years of experience in clinical trials, specializing in quality management, regulatory compliance, and risk-based study oversight. Proven ability to lead cross-functional teams, coordinate clinical operations, and drive strategic process improvements to ensure trial success. Skilled in stakeholder engagement, risk management, and protocol execution. Seeking to leverage clinical trial project management expertise to enhance operational efficiency and research excellence.

Overview

14
14
years of professional experience

Work History

Lead Quality Management Specialist

University of Maryland
11.2022 - Current
  • Company Overview: Center for Vaccine Development and Global Health
  • Led quality oversight for multiple clinical trials, ensuring protocol compliance and adherence to ICH-GCP, FDA, and IRB regulations
  • Managed cross-functional collaboration between clinical operations, data management, regulatory teams, and site staff
  • Designed and implemented risk-based quality assessments and compliance strategies, improving trial efficiency
  • Developed and enforced study protocols, SOPs, and corrective action plans (CAPAs) to mitigate risks
  • Provided training and mentorship to clinical teams, ensuring regulatory readiness
  • Center for Vaccine Development and Global Health

Senior Clinical Research Coordinator

Johns Hopkins University
01.2022 - 10.2022
  • Company Overview: Sibley Memorial Hospital
  • Coordinated multi-site oncology trials, overseeing study timelines, regulatory submissions, and protocol adherence
  • Facilitated stakeholder communication, ensuring seamless collaboration between investigators, sponsors, and site teams
  • Led the study start-up process, including IRB submissions, feasibility assessments, and patient recruitment strategies
  • Sibley Memorial Hospital

Clinical Research Coordinator

King Abdullah International Clinical Research Center
06.2011 - 02.2016
  • Supported the execution of the Saudi National Biobank initiative, ensuring regulatory compliance and data integrity
  • Coordinated research activities, including patient enrollment, informed consent, and data collection
  • Worked closely with regulatory authorities to facilitate study approvals and ensure compliance

Education

Master of Healthcare Administration -

University of Maryland Global Campus
01.2021

Graduate Certificate in Leadership & Management - undefined

University of Maryland Global Campus
08.2024

Bachelor of Medicine & Surgery - undefined

Ahfad University for Women
01.2008

Skills

  • Clinical Trial Oversight & Coordination
  • Regulatory Compliance (FDA, ICH-GCP, IRB, EMA)
  • Cross-Functional Team Leadership & Stakeholder Engagement
  • Risk Management
  • CAPA Implementation
  • Process Optimization
  • Quality Management System (QMS) Development
  • Electronic Data Capture (EDC) Systems: RedCap, Medidata Rave, Veeva SiteVault, EMMES, Informetc

Education And Certifications

Master of Healthcare Administration (MHA), University of Maryland Global Campus, 2018 - 2021, Bachelor of Medicine & Surgery (MBBS), Ahfad University for Women, 2000 - 2008, Graduate Certificate in Leadership & Management, University of Maryland Global Campus, Expected Aug 2024, CCRPS Advanced Physician Medical Monitor Certification (APMMC), 2022, ACRP: Building Quality Management Systems for Clinical Research Sites, 2024, Clinical Research Fundamentals Certification, 2022

Timeline

Lead Quality Management Specialist

University of Maryland
11.2022 - Current

Senior Clinical Research Coordinator

Johns Hopkins University
01.2022 - 10.2022

Clinical Research Coordinator

King Abdullah International Clinical Research Center
06.2011 - 02.2016

Graduate Certificate in Leadership & Management - undefined

University of Maryland Global Campus

Bachelor of Medicine & Surgery - undefined

Ahfad University for Women

Master of Healthcare Administration -

University of Maryland Global Campus
WIJDAN SULIMAN