Graduate Certificate in Clinical Trial Management

Work with the latest industry tools and learn how to apply them in the domain of Clinical Trial Management.

Overview

Why Clinical Trial Management Course

This course provides training for students to learn how the Clinical Trial Management process works, complete Regulatory activities involved in Creating Documents and Planning, Organizing, Monitoring, Recording, Analysis, and Reporting of Clinical Trials. The program provides additional opportunities to learn about recent advancements as well as specializations in e-Clinical Technology.

In This Course

Students will have 20+ weeks of hands-on training with Clinical Trial Management System and Electronic Trial Master File Management System from Site Initiation, Site Monitoring, and Closeout. This will do through real time Case Scenarios, Clinical Tasks, and other Site Management activities taught by industry experts.

Learning Outcomes

The in-house 20+ weeks of internship includes hands-on training in the Clinical Trial Management and eTMF system.The overall workflow is created as a day to day activity  and our students work as a Clinical Research Associate in a real-time environment with multiple cases to gain the knowledge and experience to be job ready from Day 1.

  • Understand and implement Site selection,Site initiation,Site monitoring and various other Site activities Activities
  • Students will assign sites, Site staff, IRB and labs to the Pre designed studies in the CTMS as a CRA
  • Students work on various Documents related to Site Visits as per the regulatory bodies requirement
  • Students will work on Site binder and trial binder in the eTMF System
  • Students will be working with documentation related to local and central IRB (Regulatory board)
  • As it is a highly regulated field, our internship program uses electronic Trial Master File (eTMF) to upload/index documents, use naming conventions and electronically sign the documents before submitting.

Highlights

Internship Program:

In our Internship program, students work in different positions in Clinicalfield to acquire experience to be job ready from Day 1.

Training:

20+ weeks of training in Clinical Trial Management System and Electronic trial Master file with cases, protocols and scenarios with full access.

Certification:

TWO Certificates, Course Completion Certificate and Internship Completion Certificate as Clinical Research Intern.

Career Guidance:

Our career service advisors provide guidance for the resume and interview preparation.

Curriculum:

Job-oriented, industry-based curriculum, full-fledged access to program content, batch recordings, and tools after one year of program completion.

References:

References for the jobs as a Clinical Research Intern.

Clinical Trials Course Modules

  • 1. Introduction to Clinical Trials
  • 2. Regulatory Framework
  • 3. Roles and Responsibilities
  • 4. Phases of Clinical Trials
  • 1. Investigational Product Management
  • 2. Protocol Development
  • 3. Patient Safety and Monitoring
  • 4. Site and Trial Management
  • 5. Trial Oversight
  • 1. Clinical Data Management
  • 2. Electronic Data Capture (EDC) Systems
  • 1. Introduction to Clinical Trial Operations
  • 2. Advanced Functions of CTO
  • 1. Clinical Project Management Basics
  • 2. Advanced Project Management
  • 1. Regulatory Affairs
  • 2. Medical Writing
  • 1. Epidemiology and Public Health
  • 2. Biostatistics
  • 1. SAS Programming for Clinical Trials
  • 2. Advanced Data Analytics
  • 1. Decentralized Clinical Trials (DCT)
  • 2. Digital Health Technologies
  • 1. Real-World Evidence (RWE)
  • 2. Patient-Centric Trials
INTERNSHIP PROGRAM

Sollers offers a 20 to 24-week, 300-hour internship that provides practical experience in clinical trials management, applying course concepts to real-world scenarios.

CAREER SUPPORT

Experts With Over 15 Years Of Professional Industrial Expertise Guiding And Coaching Students To Polish Their Resumes And Prepare For Interview Success!

LINEAGE OF A DECADE

For More Than 10 Years Sollers College Has Been Paving The Way For Education Offering Top Notch Insightful Programs Along With A Broad Alumni Network For Engagement.

Career Opportunities in Clinical Trials Management

  • Clinical Research Associate (CRA)
  • Clinical Trial Manager
  • Clinical Trial Manager
  • Regulatory Affairs Specialist
  • Clinical Project Manager
  • Clinical Research Coordinator (CRC)
  • Site Manager
  • Quality Assurance Auditor
  • Clinical Operations Specialist
  • Clinical Monitoring Lead

Course Duration

20 to 24 weeks (20+ hours each week)

3 Sessions /week

Engagement

300 hours

Program Mode

Hybrid

Get In Touch:

admissions@sollers.edu

or

Call Us Via:

73280 67846

Become a Certified
Clinical Trials Manager
Fast-track Your Life Sciences Career

100% Online | Industry-Driven Curriculum | Career Support Included

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