Qtech-Sol Professional Development Center

Clinical Research Data Management (CDMT)

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CDMT

Clinical Research Data Management (CDMT)

3 Students Enrolled
6 Weeks / 175 Hours

A Clinical Data Management specialist coordinates and manages data for clinical research studies. CDM specialist is responsible for clinical study databases and associated data.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.

Our Programs are delivered in 3 Different ways for convenience of student:
• Self-Paced Individual Program (SIP)
– Skill and Job Oriented Certificate programs, delivered as Self-Paced Online with project solutions
• Self-Paced Blended Program (SBP)
– Skill and Job Oriented Certificate programs, delivered as Self-Paced Online with project solutions. Support thru Email and Phone for queries. Student participates in 7 days Post Training Assistance program for Resume preperation
• Self-Paced Package Program (SPP)
– Skill and Job Oriented Certificate programs, delivered as Self-Paced Online with project solutions. Support thru Email and Phone for queries. Student participates in 15 days Post Training Assistance program for Resume preperation, Interview Narratives and Mock session. Obtains Job refferal and leads for application with clients and vendors

Lessons: 28 Lessons Duration: 06 Weeks / 175 Hours Language: English
Approved By:

Clinical Research Data Management program is Approved by New Jersey Department of Education and Department of Labor and Workforce, United States.

Admission Requirements:

Recommended: An Associate or bachelor’s degree in medicine, Nursing, Pharmacy, Public health Biology, Biochemistry, Biomedical engineering, Biotechnology, Chemistry, Clinical Research, Public health, Pharmacology, or toxicology, Medical Device & Technology, Psychology, Sociology and Healthcare Administration.

Scholarship:

Institutional Scholarship / Promotion is available for selected on tuition. We review your education background, certifications, and prior experiences (if applicable), to evaluate your eligibility. Qualified student will be provided with the promo code for scholarship on Tuition.
Please Email your resume to Human Resources hrs@qtech-solutions.com to check on your eligibility. We will contact you. Q-tech’s objective is to provide you the right career pathway and advancement required to meet your career goals.

Learning Outcomes:

The Benefit Student Gains

1) Upgrading the Knowledge required.
2) Better Resume Placement for promising jobs.
3) Low Investment, high learnings
4) Learn from Anywhere, Anytime at your pace.
5) Job and Title Based Tasks as followed and Practiced in industry
6) Applying Concept into Real-time (Policies, governance and tools)
7) Work on Role Based Tasks followed and Practiced in industry
8) Mocks and Narratives for Client Discussions
9) Readiness to work with limited support

Career Pathways

Our objective is to help students to meet the following career pathways. Typical Clinical Research Data Management (CDM) Job Titles the candidates can apply after this training program are :

CLINICAL DATA MANAGEMENT JOB TITLES
Clinical Data Manager Documentation Specialist
Principal Clinical Data Manager Data Analyst / SAS Programmer (CDM)
Senior Clinical Data Manager Clinical Data Analyst
CRF Designer Clinical Business Analyst
QA / QC Analyst Clinical Data Audit Manager

 

  • Curriculum Overview:

    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 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.

    CLINICAL RESEARCH DATA MANAGEMENT

    LIST OF TOPICS:

    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 - I

    SAE Reconciliation - II

    24. Elements of CRF

    25. e-CRF Design & Data Tracking

    26. Types of Reports Generated

    27. Database Locking

    28. Clinical Data Archiving

    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

Instructor

User Avatar qtech-admin

5.00 average based on 3 ratings

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Reviews

  • Maureen D

    Vinuthna D (Chicago, IL)

    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 about the practical applications needed for work. Very good course work!
  • Gamal A

    Elizabeth U (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.
  • Sangeetha T

    Pratibha T. (Seattle, WA)

    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 into Internship program to meet my career goals.

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