CLINICAL DATA MANAGEMENT
Are you passionate about clinical data analysis and planning, clinical research, database design, SAS data analysis, reporting and data modeling, and want to be part of a clinical research team to support clinical trials? This career path is best for you. You must have a bachelor’s degree in science, statistics, mathematics, computer science, biotechnology, medicine, or healthcare administration to qualify. With Qtech-Sol Clinical data management training, we strive to achieve your career goals and make you a successful clinical data manager or SAS data analyst.
CLINICAL STUDY AND TRIALS
Clinical research is medical research that involves people. Clinical trials are research conducted on people to evaluate medical, surgical, or behavioral interventions. Researchers have discovered whether new therapies / new drugs, diets, or medical devices are safe and effective for people. Often, clinical trials are used to find out whether new therapies are more effective and/or have fewer harmful side effects than standard therapies. Clinical trials of drugs are often described in terms of their stage. (I, II, III and IV).
Courses Offered
CLINICAL DATA ASSISTANT
At Qtech-Sol, we offer a beginner-level training program designed for individuals who are new to the field of Clinical Research and Data Management. The Clinical Data Assistant (CDAA) Program introduces students to the fundamentals of clinical trials and the basic responsibilities of data handling, preparing them for entry-level roles in clinical data operations.
CLINICAL TRIALS DATA MANAGEMENT
At Qtech-Sol, we are dedicated to offering specialized education and training programs in the field of Clinical Science. Our comprehensive program is tailored to meet the needs of individuals who aspire to excel as Clinical Data Managers (CDMs) in the dynamic world of clinical research. This program is meticulously designed to equip students with the essential knowledge and practical skills required for CDA and CDM roles.
AUDIT & INSPECTION READINESS (CDM)
In clinical research, audit and inspection readiness is essential to demonstrate compliance, data integrity, and process quality to regulatory agencies such as the FDA, EMA, and MHRA. For Clinical Data Management (CDM), this means maintaining accurate, complete, and inspection-ready data and documentation throughout the trial lifecycle.
INTRODUCTION TO CLINICAL DATA MANAGEMENT
Clinical Data Management (CDM) is a critical function in clinical research, ensuring that trial data is accurate, reliable, and compliant with regulatory requirements. With the increasing complexity of clinical trials, CDM professionals play a central role in data collection, cleaning, validation, and preparation for analysis and regulatory submission.
BASICS OF CLINICAL TRIAL PHASES & ROLE OF CDM
Clinical trials progress through distinct phases (I–IV), each designed to answer critical questions about a drug’s safety, efficacy, and long-term impact. At every stage, Clinical Data Management (CDM) plays a pivotal role in ensuring that data is collected accurately, cleaned systematically, and prepared for meaningful analysis.
DATA ENTRY, QUERY MANAGEMENT & DISCREPANCY RESOLUTION
High-quality data is the cornerstone of every successful clinical trial. Data entry, query management, and discrepancy resolution are critical processes in Clinical Data Management (CDM) to ensure accuracy, compliance, and regulatory readiness.
DATABASE LOCK & UNLOCK (DBL READINESS)
In clinical research, the Database Lock (DBL) is a critical milestone that signifies the end of data collection, cleaning, and validation for a clinical trial. Once the database is locked, no further changes are allowed, ensuring data integrity for statistical analysis and regulatory submission.
CASE REPORT FORM (CRF) / ECRF BASICS
The Case Report Form (CRF), whether paper-based or electronic (eCRF), is the primary tool for capturing clinical trial data. Accurate CRF design and data entry are essential to ensure the integrity, quality, and compliance of trial outcomes.
FUNDAMENTALS OF DATA VALIDATION & EDIT CHECKS
In clinical trials, data quality is non-negotiable. Clinical Data Management (CDM) teams are responsible for ensuring that data collected via Case Report Forms (CRFs/eCRFs) is accurate, consistent, and compliant with regulatory requirements. This is achieved through data validation and edit checks, which identify discrepancies, missing information, or outliers before the database is locked for analysis.
LEAD CLINICAL DATA MANAGER
The Lead Clinical Data Manager (LCDM) plays a pivotal role in overseeing clinical data operations across global trials. Beyond data entry and validation, the LCDM is responsible for strategic oversight, database design, team leadership, risk management, vendor coordination, and regulatory submission readiness.
Clinical Data Coordinators 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
The following factors considered by most clients to hire a candidate.
- Candidate – Active Vs Passive Job Seekers.
- Location Preference – Local Vs Open for relocation.
- Salary Expected – Current Vs Next.
- Skill – Fresh Vs Experienced.
- Job Title – Entry – Mid – Senior roles.
- Type of Job – Contract Vs Full-time.
- Work – Onsite Vs remote.
Qtech-Sol RMS (Resume Marketing Services) program is performed in 2 phases. The RMS program (Phase-I) is for 15 days, allowing us to focus on suitable positions to target and have your resume structured with key words per job posted by clients and have narrative form written. Your resume is the front face for clients to call you. The RMS program (Phase-II) is to support u to successfully get interviewed with mock sessions. The RMS Phase-II support is available for 60-90 days from the date your resume is finalized.
The RMS program is provided in 2 Phases.
- Phase-I (2 weeks)
- a) Resume preparation
- b) Narrative writing
- Phase-II (12 weeks)
- a) Preparing for Interview
- b) Mock Sessions
| CDM Job titles qualified after this training | |
|---|---|
| Clinical Data Manager | Clinical Data Research Specialist |
| Clinical Data Analyst | Case Report Form Designer |
| Data Quality Manager | Clinical Business Analyst |