Clinical Project Manager
Clinical Trial Management Certification
A Clinical Project Manager ensures large-scale clinical studies are carried out properly, within budget, and on time by overseeing compliance, protocol development, data collection, trial sites, and quality control. Get clinical trial management certification to become a clinical project manager.

Clinical Project Manager
The clinical trial project manager is responsible for different aspects of the clinical trial process, such as setting timelines, developing budgets, and overseeing data analysis. To become a clinical trial manager, you can gain experience in project management or clinical research roles. Clinical trial manager certification will increase your chances of getting hired.
Clinical Trial Manager
Clinical Trial Managers are responsible for planning and overseeing all aspects of clinical research projects. This includes making sure the project is conducted according to regulations and best practices. They also manage budgets, timelines, and resources to ensure the project is completed successfully.
Clinical Project Managers plan and execute clinical research projects by coordinating with internal and external stakeholders, regulatory authorities, and by develop key documents like protocols, consent forms, investigator brochures, budget sheets, study reports, and final reports.
Clinical Research Managers make sure that data is being collected and analyzed correctly, and that everyone is compliant. Clinical Project Managers design research studies and monitoring projects in terms of cost, budgeting, quality assurance, and risk assessment.
Clinical Trial Management Certification
The Clinical Trials Management Certificate program is designed to provide students with the knowledge and skills necessary to design, implement, and manage clinical trial protocols.
Clinical Trial Manager Salary
Clinical trial manager salaries vary based on experience, location, and company size. The average hourly rate for a clinical trial manager is $30-$60 per hour.
The monthly salary of a clinical trial manager typically ranges from $5,000 to $10,000. Those with more experience or who work at well-known organizations can earn up to $20,000 per month.
Annual clinical project manager salary ranges between $60,000 and $120,000 dollars per year. The median salary for a clinical trial manager is approximately $82,500 across all industries and geographies
Clinical Project Manager
Clinical Project Managers are responsible for creating project plans, timelines, budgets, and communication with vendors and stakeholders. They also provide training to personnel involved in the project, establish systems to track project progress, and identify risks associated with the project.
Clinical Research Project Manager Training
Advanced Clinical Research Associate Certification (ACRAC)
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1
Introduction
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CME Statement
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Common Terminology Used In Clinical Research - Reference Glossary
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Commonly Used Abbreviations and Terms in Clinical Research
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2
ICH GCP
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An Overview of ICH GCP
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CFR 21 Part 11
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Ethics of Research Involving Children
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Ethics of Research Involving Mentally Incapacitated
FREE PREVIEW -
Ethics of Research Involving Pregnant Women and Fetuses
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3
Fundamentals of Project Management
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Project Management Fundamentals
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PMBOK Summary - Mandatoryl Project Management Review
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Clinical Trial Project Management
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Importance of Project Management
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4
Roles and Relationships in Clinical Trials
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Role of a Project Sponsor
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ICH GCP E6 Section 5 - Sponsor/CRO Responsibilities
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Institutional Review Board/Ethics Committee (IRB/EC) (Requirements, sIRB, Application, Exemptions, Expedited Review, Continuation, and Reporting)
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Data Safety Monitoring board- DSMB
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Stakeholders in Clinical Trials (Sponsor, Project Manager, IRB, PI, CRA, CRC, Site Staff, Data Team/DSMB, Patients)
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Contract Research Organizations (Delegation, Responsibilities, Management )
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ICH GCP E6 Sections 2-4 Principles, IRB, & Investigator Roles
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ICH GCP E6 Section 4 - Reporting Responsibilities of the Investigators
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5
Skills of a Project Manager
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Essential skills of a Project Manager
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Technical skills for Project Management
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Project Team
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Managing a Project Team
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6
Project Management Documents
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Project Management Documents
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7
Regulatory Documents
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Regulatory Documents in Clinical Trials
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Delegation of Authority Log – DOAL
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Investigators Brochure (IB)
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8
Trial Master File
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Essential Regulatory Documents Binder Tab Organization (Trial Master File)
FREE PREVIEW -
Trial Master File Reference Guide
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9
New Drug Application
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The Investigational New Drug (IND) & New Drug Application (NDA) Process
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Investigator Initiated Multi-Center Trials
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IND and IDE AE Reporting
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Safety Reporting Requirements for Sponsor Investigators of An IND
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10
Problem Solving in Project Management
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Problem Solving as a Project Manager
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Project Failures and Statistics
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Project Reporting Styles
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Avoiding Project Failure
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11
Budgeting for Clinical Trials and Projects
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Project Budgeting
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Payments and Budgeting for Investigators and Site
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Advertisement Aid in Subject Recruitment and Retention
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12
Clinical Trial Design
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Advanced Designs of Clinical Trials
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Advanced Review of Phases of Clinical Trials (Preclinical & Phase 0-4)
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Randomized Controlled Trials (Randomization, Allocation Concealment, Validity, Blinding, Controls, Outcomes, Fidelity)
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Blinding and Unblinding in Clinical Trials
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The Clinical Trial Protocol - Advanced Mastery Review
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Inclusion and Exclusion Criteria in Clinical Research (Writing, Assessing for Broad vs. Narrow, Organ Dysfunction, Older Adults, Pediatrics, Pregnant Women)
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Protocol Deviations and Violations (Major, Minor, Exceptions, Resolution)
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13
Project Management Scheduling and Tracking
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Basics of Project Scheduling
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Project Progress Tracking
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Project Management Planning Process
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14
Project Management Plan
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Project Management Planning Process
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Closing a Project
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Project Delays
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Process Mapping
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Metric Tracking
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15
Duties of a Successful Project Manager
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Roles and Responsibilties of a Project Manager
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Project Management Success Factors
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16
Adverse Events
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Advanced Review of Adverse Events
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17
Site Selection and Visits
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Types of Monitoring Visits (Selection, Initiation, Routine, Close-Out)
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Site and Investigator Selection Criteria (Process, Criteria, Investigator Selection, Agreements, Decision-Making)
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Site Selection/Qualification Pre-Study Visit (SSV/SQV) (Before, During, After, Letters, Checklists, and Report)
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18
Audit and Inspections
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Audits and Inspections in Clinical Trials
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Clinical Trial Data Audits
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FDA Warning Letter
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19
Quality Control and Safety
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Quality Control in Clinical Trials ( QC/QA, KQI, QMS, Checklist)
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ICH GCP - Safety of Human Subjects in Clinical Research
FREE PREVIEW
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20
Technology in Trials (IVRS, CTMS, EDC)
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Clinical Trial Management System-CTMS
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ICH GCP - Trial Management, Data Handling, and Record Keeping
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An Overview of Remote Monitoring - COVID-19 Update
FREE PREVIEW -
Centralized Monitoring
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Interactive Response Technologies in Clinical Trials (IVRS, IWRS, IRT, RTSM)
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21
Pharmacovigilance and Regulatory Affairs
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Advanced Practice of Pharmacovigilance
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Regulatory Affairs for Clinical Trials
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22
Investigational Product and Labs
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Investigational Product Storage and Dispensing
FREE PREVIEW -
Investigational Product Accountability in Clinical Trials
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Local and Central Labs in Clinical Trials (Local, Regional, Central, GLCP, CLIA Cert, Lab Audit Checklist)
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23
Patient Recruitment, Retention, and Compliance
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Patient Recruitment in Clinical Trials
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Patient Engagement and Retention in Clinical Trials
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Patient Adherence and Compliance in Clinical Trials
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24
Project Manager Job Readiness
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Project Manager Skills Interview Questions
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Interview Questions
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25
Competency Examination
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Competency Exam
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