LEAD CLINICAL DATA MANAGER - Qtech-Sol offers Clinical Research / Trials, Pharmacovigilance, Drug Safety, Clinical Data Management, Clinical SAS Programming and Healthcare BA Training Programs
Category:
Data Management
 
Duration:
6 Weeks / 110 Hours
 
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Lead Clinical Data Manager

Introduction – 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.
The LCDM program is designed for experienced Clinical Data Managers who aspire to move into leadership and project management roles within data management departments of pharmaceutical companies, CROs, and academic research organizations.

Course Name :  Lead Clinical Data Manager
Course Code :  LCDM
Experience Level :  Advanced
Qualification :  Bachelor’s / Master’s in Life Sciences, Statistics, Computer Science, or related fields
Student Category :  Experienced CDMs, Senior Data Coordinators, Data Leads preparing for management roles

Delivery Type

SIP – Self-Paced Online with Support

Duration & Delivery
  1. Course Duration: 3 weeks (80 hours)
  2. Format: Self-Paced Online with Support (narrated lessons, readings, quizzes, and role-based tasks).
Key Learning Objectives

   By completing this program, learners will:

  2. Understand the end-to-end responsibilities of a Lead CDM in global trials.
  3. Gain expertise in database design, setup, and validation (EDC, CRFs, edit checks).
  4. Learn project management skills for leading CDM teams and deliverables.
  5. Oversee data cleaning, query management, and discrepancy resolution at the trial level.
  6. Manage risk assessment, timelines, and resource planning.
  7. Coordinate with cross-functional teams (Biostatistics, Clinical Operations, Pharmacovigilance, Regulatory).
  8. Ensure regulatory compliance (ICH-GCP, FDA, EMA, 21 CFR Part 11).
  9. Lead database lock (DBL) readiness and submission deliverables.
  10. Develop leadership, communication, and vendor management skill
Who Should Take This Course

This course is ideal for:

  1. Experienced CDMs seeking leadership advancement.
  2. Senior Data Coordinators / Associates preparing for CDM Lead roles.
  3. Project Managers in Clinical Operations transitioning into CDM leadership.
  4. Data professionals aiming for management-level roles in CROs and pharma.
Benefits & Outcomes

This program is ideal for:

  1. Gain strategic leadership skills in CDM.
  2. Learn to lead multi-study/global trial operations.
  3. Strengthen regulatory compliance and inspection readiness expertise.
  4. Build confidence in vendor management and cross-functional collaboration.
  5. Be prepared for senior positions such as CDM Lead, Data Operations Manager, or Associate Director of Data Management.
Career Pathways: After completing this course.

This program is aligned with:

  1. Lead Clinical Data Manager (LCDM)
  2. Senior CDM / CDM Lead
  3. Clinical Data Operations Manager
  4. Associate Director, Data Management
  5. Head of Clinical Data Management

Curriculum & Modules

Modules
1. Role & Responsibilities of a Lead Clinical Data Manager

2. Advanced Database Design & CRF/eCRF Oversight

3. Edit Check Strategy & Validation Planning

4. Query Management at the Study Level

5. Project & Team Management Skills for CDM Leads

6. Vendor Oversight & Collaboration in Outsourced Trials

7. Risk Management & Mitigation in Data Operations

8. Data Standards (CDISC SDTM, ADaM, Define.xml) for Submissions

9. Audit & Inspection Readiness for CDM Leads

10. Database Lock (DBL) Leadership & Unlock Strategies

11. Case Studies – Leading Global Trials in Pharma & CROs
Getting in Touch:

For more information, please call us at +91 8925971788 / +91 8977943100 (WhatsApp) or email qpdc@qtechelearncenter.com. Our course specialists will reach out to you promptly to assist you in taking the next steps toward your career goals.