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.

How to become a clinical trial 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.

  • To become a clinical project manager, one must first obtain a Bachelor's degree in a health-related field. Additionally, developing skills for project management and participating in relevant courses are necessary.
  • Experience can be gained by volunteering or interning in clinical trials with pharmaceutical companies or medical research centers.
  • Pursuing an advanced degree or getting certified as a Clinical Project Manager with open up more opportunities.
What is a clinical manager
Clinical Trial Manager
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 Manager

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 Manager

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 Trials Management Certificate
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.

  • This Clinical Trials Design & Management Certificate Program introduces learners to the fundamentals of clinical trials design and management.
  • The program covers principles and regulations of clinical trial design, analysis techniques for statistical analysis, quality control and assurance, data management and reporting.
  • Students will also gain an understanding of risk assessment strategies, study site selection, protocol implementation and monitoring, resource management as well as safety requirements for conducting clinical trials.
Clinical Manager Salary
Clinical Trial Manager Salary
Clinical 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.

Clinical trial manager salary

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.

Clinical project manager salary

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

What does a Research Project Manager do?
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 Project Managers make sure that clinical research projects go well by working groups like contract research organizations (CROs), internal departments, and external vendors. Clinical Project Managers make sure that projects follow the research protocols, good clinical practices (GCPs), applicable regulations, and standards
  • Research Project Managers also develop protocols for data collection and analysis, prepare reports for regulatory submissions, coordinate activities related to safety monitoring, and provide support to staff during project-related training sessions or workshops.
  • Trial Project Managers make sure that data is collected accurately according to guidelines from the FDA or EMA. This includes finding risks associated with the project; assessing their impacts; planning ways to reduce the risks; and also planning how to use resources so that everything runs smoothly.

Clinical Research Project Manager Training

Advanced Clinical Research Associate Certification (ACRAC)

  • 1

    Introduction

    • CME Statement

    • Common Terminology Used In Clinical Research - Reference Glossary

    • Commonly Used Abbreviations and Terms in Clinical Research
  • 2

    ICH GCP

  • 3

    Fundamentals of Project Management

    • Project Management Fundamentals

    • PMBOK Summary - Mandatoryl Project Management Review

    • Clinical Trial Project Management

    • Importance of Project Management
  • 4

    Roles and Relationships in Clinical Trials

    • Role of a Project Sponsor

    • ICH GCP E6 Section 5 - Sponsor/CRO Responsibilities

    • Institutional Review Board/Ethics Committee (IRB/EC) (Requirements, sIRB, Application, Exemptions, Expedited Review, Continuation, and Reporting)

    • Data Safety Monitoring board- DSMB

    • Stakeholders in Clinical Trials (Sponsor, Project Manager, IRB, PI, CRA, CRC, Site Staff, Data Team/DSMB, Patients)

    • Contract Research Organizations (Delegation, Responsibilities, Management )

    • ICH GCP E6 Sections 2-4 Principles, IRB, & Investigator Roles

    • ICH GCP E6 Section 4 - Reporting Responsibilities of the Investigators
  • 5

    Skills of a Project Manager

    • Essential skills of a Project Manager

    • Technical skills for Project Management

    • Project Team

    • Managing a Project Team
  • 6

    Project Management Documents

    • Project Management Documents
  • 7

    Regulatory Documents

    • Regulatory Documents in Clinical Trials

    • Delegation of Authority Log – DOAL

    • Investigators Brochure (IB)
  • 8

    Trial Master File

  • 9

    New Drug Application

    • The Investigational New Drug (IND) & New Drug Application (NDA) Process

    • Investigator Initiated Multi-Center Trials

    • IND and IDE AE Reporting

    • Safety Reporting Requirements for Sponsor Investigators of An IND

  • 10

    Problem Solving in Project Management

    • Problem Solving as a Project Manager

    • Project Failures and Statistics

    • Project Reporting Styles

    • Avoiding Project Failure
  • 11

    Budgeting for Clinical Trials and Projects

    • Project Budgeting

    • Payments and Budgeting for Investigators and Site

    • Advertisement Aid in Subject Recruitment and Retention
  • 12

    Clinical Trial Design

    • Advanced Designs of Clinical Trials

    • Advanced Review of Phases of Clinical Trials (Preclinical & Phase 0-4)

    • Randomized Controlled Trials (Randomization, Allocation Concealment, Validity, Blinding, Controls, Outcomes, Fidelity)

    • Blinding and Unblinding in Clinical Trials

    • The Clinical Trial Protocol - Advanced Mastery Review

    • Inclusion and Exclusion Criteria in Clinical Research (Writing, Assessing for Broad vs. Narrow, Organ Dysfunction, Older Adults, Pediatrics, Pregnant Women)

    • Protocol Deviations and Violations (Major, Minor, Exceptions, Resolution)
  • 13

    Project Management Scheduling and Tracking

    • Basics of Project Scheduling

    • Project Progress Tracking

    • Project Management Planning Process
  • 14

    Project Management Plan

    • Project Management Planning Process

    • Closing a Project

    • Project Delays

    • Process Mapping

    • Metric Tracking
  • 15

    Duties of a Successful Project Manager

    • Roles and Responsibilties of a Project Manager

    • Project Management Success Factors

  • 16

    Adverse Events

    • Advanced Review of Adverse Events
  • 17

    Site Selection and Visits

    • Types of Monitoring Visits (Selection, Initiation, Routine, Close-Out)

    • Site and Investigator Selection Criteria (Process, Criteria, Investigator Selection, Agreements, Decision-Making)

    • Site Selection/Qualification Pre-Study Visit (SSV/SQV) (Before, During, After, Letters, Checklists, and Report)
  • 18

    Audit and Inspections

    • Audits and Inspections in Clinical Trials

    • Clinical Trial Data Audits

    • FDA Warning Letter
  • 19

    Quality Control and Safety

  • 20

    Technology in Trials (IVRS, CTMS, EDC)

  • 21

    Pharmacovigilance and Regulatory Affairs

    • Advanced Practice of Pharmacovigilance

    • Regulatory Affairs for Clinical Trials
  • 22

    Investigational Product and Labs

  • 23

    Patient Recruitment, Retention, and Compliance

    • Patient Recruitment in Clinical Trials

    • Patient Engagement and Retention in Clinical Trials

    • Patient Adherence and Compliance in Clinical Trials

  • 24

    Project Manager Job Readiness

    • Project Manager Skills Interview Questions

    • Interview Questions
  • 25

    Competency Examination

    • Competency Exam

The most advanced clinical trial project management training available

  • Take the fast track

    Take the fast track to a lucrative career as a Clinical Research Project Manager to start earning salaries of $100k+

  • Get advanced training

    Get the most advanced training - ACRPM is recognized as a gold standard by many CROs in the industry thanks to its comprehensive training

  • Work at your own pace

    Work at your own pace from wherever you are with flexible online training. The 100+ modules included can be completed in as little as 2 weeks

  • Requirements

    Designed for those holding a minimum of a BA in Science, ACRPM is internationally accredited to ACCRE, ACCME, ACPE, ANCC, and Transcelerate Biopharma. In other words, upon completion of the course and the final exam, you will have a level of knowledge equivalent to (and beyond!) that of a senior CRA.

  • Syllabus

    ACRPM features 100+ modules, or 250 hours, of on-demand online training (worth 17.5 CME credits). The course has been put together by clinical trial project managers, enabling students to build a deep knowledge of the industry.

  • Certification

    This course can be completed in as little as two weeks, with certification and a letter of recommendation awarded after completing a final exam. ACRPM also provides you with tools to help you find a job, including resume and interview guides, giving you a further edge over other applicants for the same position.