Clinical Data Management | CDM Training
Category:
Data Management
 
Duration:
06 Weeks / 175 Hours
 
Price:
$1,094.00 $711.00
 
 

Qtech-Sol CDM Certificate Course

Clinical Trials Data Management

Qtech-Sol is a Clinical Science Training Provider. This course provides Foundation learning to work as Clinical Data Management Specialist or Manager. This is a job and title focused program. The course emphasizes about role of CDM towards clinical data capture, validating, auditing, and reporting tasks. The course curriculum is designed to give an edge to obtain job as CDM with Pharmaceuticals, Biotech, Medical Device, Clinical Research Organizations (CROs) and with Research Clinics.

Course Name :  Clinical Trials Data Management
(Role based Lessons – Case Scenarios, Job Tasks with Solutions)
Code :  CDMT
Duration :  6 Weeks / 175 Hours
Delivery : Self-Paced Online with Support.
(Qtech-Sol Learning Management System (Q-LMS)
Course Material : This course contains and delivers 28 Lessons.
Each Lesson contains various delivery modes as presentation with voice over, course reading material (chapters), Quizzes for Practice (15 Set) and Test (10 Set), Short Questions, Role based Tasks (Exercises, along with solutions).
Course Brochure : Download BROCHURE
Course Demo : Register for COURSE DEMO
Fill out Registration form and select module name Clinical Sciences and select “clinical data management” course.
You will receive an email with weblink to self-activate your demo course.
Upon activation will have access to 4 lessons for next 5 days.
Online Discussion : Book your slot for a personalized ONE-O-ONE discussion with us. You will receive an online invite to participate via email.
Fees : $1,094.00 USD
Now Only $711.00    BUY NOW
Application Form : APPLY NOW
To complete your enrollment, please email your resume to qpdc@qtech-solutions.com
Introduction

Clinical Data Manager or Coordinator handle clinical information like patient records, appointments, studies, and other official documents. Their role is coordinating activities that relate to clinical administrative tasks and recording data for study and validation. Clinical data managers are responsible for collecting data from a variety of medical research projects, such as clinical and pharmaceutical trials. They work collaboratively to make sure data is collected, managed, reported clearly, accurately and securely.

Course Enrollment process

Qtech-Sol offers self-paced online courses. Student get started with the course when they are ready. They must complete the online application, pay applicable tuition and submit required credentials. Student must submit their resume and copy of highest degree certificate obtained. These documents are used to validate the student’s name on certificate, contact information, course enrolled and their education eligibility to participate.

Start to Finish Steps:
  1. Submit Online Application
  2. Pay applicable tuition (Shopping cart)
  3. Email credentials required
  4. Receive Course Activation email
  5. Obtain access to Course and Solution bank (LMS)
  6. Receive support for subject related queries.
  7. Submit Course task deliveries per schedule shared
  8. Take Final exam upon completing he course
  9. Obtain Course completion certificate and transcript
  10. Get Started with PTA program for next steps
Gaining experience

An Ideal person must have bachelor’s degree in degree in life science or other health-related discipline to become a CDM Specialist. Qtech-Sol CDM Coursework is not wet lab experience, these are computer related roles performed using clinical data and tools, to support the progress of clinical trials being conducted. Person must have basic computer knowledge and works with Microsoft Word, Excel, Notepad, PowerPoint etc. The ideal person works within pharmaceutical or at hospital and research centers.

The Clinical Research Data Management training program offered at Qtech provides insights into Clinical Research Data Management activities along with exposure to real-time documentation and scenarios pertaining to roles and responsibilities performed by Clinical Data Management specialist. Qtech provides in-depth into the core area of clinical data management like Clinical data and its quality, data management plan, data entry, Clinical Research Data Management Systems (CDMS), Clinical data repository, loading of external data into CDM, Query management, data clarification form, database locking, patient diary, data cleaning and validation, and database archiving. The students will get practical exposure to real-time documentation and scenarios for Data Management Plan, Query Management, Coding of Adverse Events, SAE Reconciliation, Data Cleaning and Data Validation, Elements of CRF, e-CRF designing, Data tracking from CRF, and Types of Reports generated.

Examples of job titles to apply
  1. Clinical Data Manager
  2. Clinical Research Data Analyst
  3. Clinical Data Associate
  4. Case Report Form Designer
  5. Data Quality Manager
  6. Clinical Business Analyst

  • Eligible Education:

    Recommended: An Associate or bachelor’s degree in Statistics, Biostatistics, Biotechnology, Economics, Computer Science, Engineering, Cognitive Science, Data Science, Machine Learning (ML), Artificial Intelligence (AI), Mathematics.

    Post Training Assistance

    Your resume is front face to hiring recruiters and organizations to pre-screen or call for an interview. With competition out in market, does your resume meet the requirements. Contact us to participate in our Post Training Assistance (PTA)” program for resume build, interview narratives, and mock. It is as well important to know, the current hiring organizations in your area, open positions available, salary range, fitness of resume to apply and many more. During this PTA program you will have opportunity to discuss with our course specialist to learn and discover opportunities in small steps. We shall work together as team to achieve this goal.

  • Learning Outcomes:
    The Benefit Student Gains
    • Upgrading the Knowledge required.
    • Better Resume Placement for promising jobs.
    • Low Investment, high learnings
    • Learn from Anywhere, Anytime at your pace.
    • Job and Title Based Tasks as followed and Practiced in industry
    • Applying Concept into Real-time (Policies, governance and tools)
    • Work on Role Based Tasks followed and Practiced in industry
    • Mocks and Narratives for Client Discussions
    • Readiness to work with limited support
  • Professional organizations

    Professional organizations and associations are membership-based groups comprised of people working in a similar field. They can be helpful resources for students to learn more about a field, develop connections and discover related opportunities.

    Check out World-Wide Clinical Resource Information. Follow the resource links to learn what’s happening around the world on current news and updates about Clinical trials, Regulatory, CDM and Pharmacovigilance.

    Reviews

    Qtech-Sol has trained since 2000, many candidates with different education background and skills. Few of them are currently working as directors in top MNC companies.

    The program gave me an in-depth understanding of the role of a CDM in Clinical Research and Trial Management Teams. With the practical examples and lectures from professionals, I gained a clear understanding of the practical applications needed for work. Very good course work!

    – Vinuthna D (Chicago, IL)

    The best part about CDM training is presentations which clearly mention the important and key points that are helpful for building basics in the subject. I found the exercises helpful in understanding the format on how to fill the forms and analyzing the data which will be useful in real-time for me.

    – Elizabeth U (New Jersey)

    I am a Biomedical Science graduate. This Certificate training helped me to understand the Job-related work process better. The Clinical Data Management training program offered at Qtech is very useful for beginners, I liked it and highly recommend others. Currently, I am enrolled in an Internship program to meet my career goals.

    – Pratibha T. (Seattle, WA)

    Getting Connected

    For additional information please call us on 732.770.4100 or ENQUIRE. One of our course specialists will contact you at earliest possible.

Curriculum Overview

Program is designed by industry experts meeting job and title-based learnings needed for students and young professionals to get into jobs. The training provides in depth knowledge of roles and responsibilities of Clinical Data Manager / Coordinator. The curriculum includes theoretical and practical aspect of the role and tasks performed on day-to-day basis, along with exposure to various exercises per industry requirements.

Clinical Trials Data Management
Lessons Offered

1. Introduction to Clinical Trials

2. Phase I Clinical Trials.

3. Phase II Clinical Trials.

4. Phase III Clinical Trials.

5. Phase IV Clinical Trials.

6. Good Clinical Practice and ICH Guidelines

7. SOP Development

8. Communication with Cross Functional Team

9. Introduction to Clinical protocol

10. Foundation of Clinical Data Management

11. Good Clinical Data Management Practices (GCDMP)

12. Data Management Plan

13. Clinical Trial Data and Its Quality

14. Clinical Data Management System

15. Clinical Data Repository

16. Loading the external data into the CDM system

17. Exporting Data to DMC

18. Clinical trial data cleaning and validation

19. Query Management

20. Data Clarification Form

21. Patient Diaries & Patient Reported Outcome

22. Remote Data Entry

23. Clinical Data Entry, SAE Reconciliation

24. Elements of CRF

25. e-CRF Design & Data Tracking

26. Types of Reports Generated

27. Database Locking

28. Clinical Data Archiving

Job focused exercises

CASE 1. Introduction to Clinical Trials

CASE 2. Protocol Design and Development

CASE 3. Data Management Plan

CASE 4. Data Cleaning and Data Validation.

CASE 5. Query Management.

CASE 6. Coding of Adverse Events.

CASE 7. SAE Reconciliation.

CASE 8. Elements of CRF.

CASE 9. e-CRF designing Data tracking from CRF

Getting Connected

For additional information please call us on 732.770.4100 or ENQUIRE. One of our course specialists will contact you at earliest possible.

  • The program gave me an in-depth understanding of the role of a CDM in Clinical Research and Trial Management Teams. With the practical examples and lectures from professionals, I gained a clear understanding of the practical applications needed for work. Very good course work!

    Vinuthna D (Chicago, IL)Ramya I (New Jersey)

  • The best part about CDM training is presentations which clearly mention the important and key points that are helpful for building basics in the subject. I found the exercises helpful in understanding the format on how to fill the forms and analyzing the data which will be useful in real-time for me.

    Elizabeth U (New Jersey)

  • I am a Biomedical Science graduate. This Certificate training helped me to understand the Job-related work process better. The Clinical Data Management training program offered at Qtech is very useful for beginners, I liked it and highly recommend others. Currently, I am enrolled in an Internship program to meet my career goals.

    Pratibha T. (Seattle, WA)