CLINICAL RESEARCH DATA MANAGEMENT – TRAINING AS INTERNSHIP

Title : CLINICAL RESEARCH DATA MANAGEMENT (TRAINING PROGRAM AS INTERNSHIP)

Industry: Pharmaceuticals, Research, and Hospitals

Training Program.

Qtech-Sol Training division doing business as Qtech-Sol Professional Development Center (QPDC) is a Private Vocational School and its Clinical Science programs are approved by New Jersey State - Department of Education and New Jersey Department of Labor and Workforce Development. We primarily engage in offering an array of short duration certificate courses for corporate, professionals and students. Our CDMT Package program offered, allows you to focus on securing a career advancement job.

CDM Certification and Job Oriented Program (CDMT).

1. Clinical Research Data Management (CDM) - Certification program - 45 Days
2. Post Training Assistance (Resume Prep, Narratives, and Mock Session) - 15 Days

This program allows you to better place your profile with clients for possible jobs. The job market requires experience and understanding of Clinical Research Data Management and the Job tasks performed. Qtech-Sol packageprogram,will provide the required experience to jump-start.

This Training Program as Internship provides students hands-on about the various tasks and duties performed by Clinical Research Associate at Pharmaceutical, Hospital, and Research Organizations towards conduction of Clinical Research Data Management and project management tasks. This Training program is Unpaid Internship and is conducted for 6 Weeks to Fresh and Alumni Students. Selection of Student is based on education background and GPA, subject to Interview performance. Student will participate into this program remotely. Students attending the Training program must plan to spend minimum 4 hours/ day to submit the deliverables per schedule. The lessons will educate the student on the CDM task to perform, client settings followed in Industry, team-work and submit timely the allocated deliverable tasks as part of this learning. During this Training Program, the candidate will have access to Qtech Proprietary forms, data and related presentations. The Student will be exposed to various CDM Job related hypothetical tasks to gain required experience. The tasks are evaluated and feedback is provided via email. Candidates who have successfully completed the Internship, will be provided a certificate of completion. The student will take a final certificate exam at the end of this training program. Applicable fees apply to participate in this program.

Learning’s Gained during this Training Program.

• Introduction to Clinical Trials
• Phase I Clinical Trials.
• Phase II Clinical Trials.
• Phase III Clinical Trials.
• Phase IV Clinical Trials.
• Good Clinical Practice And ICH Guidelines
• SOP Development
• Communication With Cross Functional Team
• Introduction to Clinical protocol
• Foundation of Clinical Data Management
• Good Clinical Data Management Practices (GCDMP)
• Data Management Plan
• Clinical Trial Data and Its Quality
• Clinical Data Management System
• Clinical Data Repository
• Loading the external data into the CDM system
• Exporting Data to DMC
• Clinical trial data cleaning and validation
• Query Management
• Data Clarification Form
• Patient Diaries & Patient Reported Outcome
• Remote Data Entry
• Clinical Data Entry - I
• SAE Reconciliation - II
• Elements of CRF
• e-CRF Design & Data Tracking
• Types of Reports Generated
• Database Locking
• Clinical Data Archiving