Structure

Week 1: Foundations of Clinical Trial Management

Class 1: ICH-GCP Principles and Clinical Research Overview

• Introduction to ICH, harmonization, and principles of Good Clinical Practice (GCP).
• Overview of clinical trial management within drug development.
• Key roles and responsibilities of a Clinical Trial Manager (CTM).

Class 2: Regulatory Frameworks and Sponsor Responsibilities

• Understanding the regulatory frameworks in the US (FDA), EU, and globally.
• Sponsor responsibilities: investigator selection, trial management, safety reporting, and data handling.
• Introduction to investigational new drug (IND) applications and EU Clinical Trial Authorization (CTA) processes.

Week 2: Clinical Trial Design and Site Management

Class 1: Protocol Design and Study Endpoints

• Elements of clinical trial protocols and opportunities for optimization.
• Importance of clinical endpoints and statistical elements in trial design.
• Key considerations for data capture and regulatory compliance.

Class 2: Site Evaluation and Set-Up

• Investigational site qualification: assessing site suitability and conducting site initiation visits.
• Preparing for trial initiation: TMF review, training personnel, and confirming monitoring plans.
• Addressing site-specific challenges during set-up.

Week 3: Documentation, Compliance, and Risk Management

Class 1: Essential Documentation and Good Practices

• Overview of essential documents (TMF, investigator’s regulatory binder).
• Principles of Good Documentation Practices (GDP) and ALCOA-C standards.
• Managing protocol amendments, informed consent changes, and safety reports.

Class 2: Risk-Based Monitoring and Compliance

• Principles of risk-based monitoring: centralized vs. on-site monitoring.
• Strategies for managing noncompliance and addressing fraud or scientific misconduct.
• Tools for ensuring data integrity and compliance with evolving regulatory landscapes.

Week 4: Trial Conduct and Oversight

Class 1: Site Monitoring and Close-Out Activities

• Responsibilities of site monitoring visits: assessing compliance and resolving discrepancies.
• Steps for effective source document verification (SDV) and query resolution.
• Conducting trial close-out visits: document retrieval and site decommissioning.

Class 2: Global Drug Development and Commercial Considerations

• Overview of drug development stages: discovery, nonclinical, and clinical phases.
• Impact of global markets, financial risk, pharmacoeconomics, and regulatory changes on trial management.
• Best practices for managing trials with global and multicenter components.

Week 5: Audits, Leadership Development, and Career Preparation

Class 1: Preparing for Audits and Inspections

• Principles of GCP inspections and audits: purpose, scope, and possible outcomes.
• Preparing investigator sites for sponsor or regulatory audits.
• Post-inspection actions: addressing findings and implementing corrective action plans.

Class 2: Leadership Skills and Mock Interviews

• Developing leadership and communication skills for CTM roles.
• Resume building and interview preparation tailored for Clinical Trial Manager positions.
• Simulated interviews with expert feedback to build confidence and competence.

Tangible Benefits:

• ✔ Career Readiness in 5 Weeks
• ✔ Resume and Interview Prep
• ✔ On-the-Job Support

Career Benefits:

• 🌍 Remote and Hybrid Work Opportunities
• 💸 Salary Potential: $145,000 - $187,000