Zeeshan I.
Task Area Manager Lead Cra @Technical Resources International, Inc.
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WORK HISTORY
Task Area Manager Lead Cra @Technical Resources International, Inc.
Provides comprehensive site management and monitoring support for the Center for Cancer Research (CCR), ensuring adherence to study protocols and regulatory requirements.• Conducts various clinical monitoring visits, including Site Initiation Visits (SIVs), Interim Monitoring Visits (IMVs), and Close-Out Visits (COVs), ensuring all activities comply with study protocols, Standard Operating Procedures (SOPs), ICH GCP guidelines, FDA regulations, and other applicable standards.• Serves as a liaison between the project team, line management, and clinical sites, facilitating effective communication and resolution of study-related issues.• Provides leadership and operational direction to the clinical operations study team, including day-to-day management of Clinical Research Associates (CRAs).• Oversees the assignment and completion of project-specific training for CRAs, ensuring competency in study-related tasks.• Develops and provide input on the development of SOPs, study tools, monitoring tools, presentations, meeting materials, timelines, monitoring plans, site reference documents, and training materials, contributing to continuous improvement and process optimization.• Collaborates with other departments to support study management tasks, with a focus on leading regulatory document review activities.• Ensures implementation and adherence to SOPs and processes, promoting consistency and quality in clinical operations.• Assists department leadership in identifying training and development needs and opportunities for staff members, contributing to the professional growth and development of the team.• Prepares for and participate in audits and inspections, including responding to any issues identified within the required timeframe.• Possesses extensive experience in Phase 1-3 trials, with a thorough understanding of clinical operations, the clinical development process, ICH/GCP guidelines, and the regulatory environment.
EDUCATION
University of Medicine and Dentistry of New Jersey
Cytotechnology certification (ASCP)
Aureus university school of medicine
Pursuing MD
Davenport University
Master of Business Administration - MBA, Health/Health Care Administration/Management
Bayonne high school
High school diploma
Saint Peter's University
Bachelor of Science - BS
ABOUT ZEESHAN I.
Experienced and driven leader with a demonstrated history of working in the Healthcare industry. Skilled in Medical terminology, Research, Analytical Skills, Microsoft, Communication, Account Management, and Leadership. Strong education professional graduated from Davenport University with background in medicine.
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