Lead Clinical Data Manager (LCDM) – Qtech-Sol USA offers Clinical Research / Trials, Pharmacovigilance, Drug Safety, Clinical Data Management, Clinical SAS Programming and Healthcare BA Training Programs
Category:
Data Management
 
Duration:
8 Weeks / 160 Hours (Self-Paced)
 
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Lead Clinical Data Manager (LCDM)

Introduction – Clinical Trials Data Management

At Qtech-Sol, we provide specialized professional-development programs that prepare learners to lead modern Clinical Data Management (CDM) operations. The LCDM program is designed for professionals who already possess foundational CDM experience and are ready to advance into leadership and oversight roles within pharmaceutical, biotechnology, or CRO environments.

Clinical Data Managers play a mission-critical role in safeguarding the accuracy, integrity, and regulatory compliance of clinical-trial data. As clinical-research protocols grow more complex, the ability to manage diverse datasets, systems, and timelines becomes essential. The Lead CDM oversees the entire data-management lifecycle—from study startup to database lock—while mentoring team members and ensuring adherence to Good Clinical Data Management Practices (GCDMP) and CDISC standards.

This advanced curriculum emphasizes leadership, process control, cross-functional coordination, and data-quality governance. Participants will gain practical knowledge of regulatory frameworks (FDA 21 CFR Part 11, ICH-GCP), sponsor oversight expectations, and industry-standard tools for data collection, validation, cleaning, and submission readiness.

Course Name : Lead Clinical Data Manager (LCDM)
Course Code : LCDM
Experience Level : Advanced / Lead
Qualification : Bachelor’s / Master’s in Life Sciences or Related Field
Student Category : Working Professional / Career Advancer

Course Material Includes

29 role-based lessons covering leadership functions, team coordination, and real-world case scenarios. Each lesson offers multiple learning modes – Narrated Presentations, Reading Material, Quizzes, Assessment Tests, Short Questions, and Role-Based Tasks with solutions.


Delivery Type

SIP – Self-Paced Online with Support


Course Duration

8 Weeks / 160 Hours (Self-Paced)


Learning Focus Areas
  1. Lead study-level data management planning and execution
  2. Develop and maintain Data Management Plans (DMPs) and CRF completion guidelines
  3. Implement GCDMP and CDISC standards across projects
  4. Coordinate with cross-functional teams (Biostatistics, Clinical Operations, Safety)
  5. Oversee database design, UAT testing, and mid-study updates
  6. Supervise data validation, cleaning, and discrepancy resolution activities
  7. Manage external vendor data (labs, ECG, ePRO) integration and QC
  8. Ensure audit readiness and regulatory compliance (21 CFR Part 11, GDPR / HIPAA)
  9. Perform database lock and deliver clean datasets for statistical analysis
  10. Mentor junior CDMs and coordinate team deliverables

Educational Requirements

Applicants should hold a Bachelor’s or Master’s degree in life sciences or a related discipline such as Biology, Pharmacy, Public Health, Biochemistry, Biotechnology, or Biomedical Engineering. Prior experience in clinical data management or clinical research is recommended for entry into this advanced-level course.


Building Relevant Experience

The LCDM program equips participants to lead multi-study data management teams, drive cross-functional communication, and handle data governance for regulatory submissions. Through real-world scenarios and hands-on tasks, learners gain competence in vendor oversight, risk-based data review, AI-assisted reconciliation, and inspection readiness.

Graduates are prepared for titles including:

  1. Lead Clinical Data Manager / Project CDM Lead
  2. Data Operations Manager / Team Lead
  3. Clinical Data Governance Specialist
  4. Clinical Database Administrator
  5. CDISC Standards Implementation Lead

Key Learning Outcomes and Benefits
  1. Master protocol-to-database translation and validation strategy design
  2. Ensure end-to-end data integrity and regulatory compliance
  3. Gain expertise in CDISC (SDTM, ADaM) and submission deliverables
  4. Strengthen leadership skills for team supervision and sponsor oversight
  5. Enhance resume and career readiness through our Post-Training Assistance (PTA)
  6. Access mentorship and mock interviews for transition to lead roles

Professional Development & Support

Upon completion, learners gain access to Qtech-Sol’s Resume Marketing Services (RMS) and Post-Training Assistance (PTA). These services help students optimize their resumes, prepare for interviews, and connect with employers seeking lead-level CDM talent.

Support Includes:

  1. Resume & LinkedIn Optimization
  2. Narrative and Interview Preparation
  3. Mock Interviews
  4. Job Search Guidance & Market Insights

Overview of the Curriculum
Modules
1. Data Management Plan (DMP) Development: Design, implement, and maintain study-specific DMPs ensuring full alignment with protocol and sponsor expectations.
2. CRF / eCRF Design and Completion Guidelines: Lead cross-functional CRF design reviews and finalization, incorporating edit-check logic and data flow requirements.
3. Edit Checks and Validation Specifications: Supervise edit-check programming and validation testing to ensure clean and accurate data capture.
4. External Data Imports and Integration Processes: Manage data from external vendors (Labs, ECG, Imaging, ePRO) and oversee reconciliation workflows.
5. Medical Coding (MedDRA / WHO-DD): Oversee auto-coding setup and medical coding QC processes for safety and concomitant medication data.
6. SAE Reconciliation and Safety Data Exchange: Ensure efficient reconciliation between clinical and safety databases to maintain data consistency and compliance.
7. Data Transfer Agreements and Vendor Oversight: Develop data transfer specifications and manage vendor deliverables through governance and performance KPIs.
8. Database Testing and UAT Execution: Lead end-to-end testing of EDC systems and edit-checks, managing UAT cycles and signoff documentation.
9. Risk-Based Data Review and Central Monitoring: Implement risk-based data review plans, interpret centralized monitoring dashboards, and act on risk indicators.
10. Audit Trails & Regulatory Compliance: Monitor audit trail compliance, manage 21 CFR Part 11 documentation, and support regulatory inspections.
11. Lock, Freeze, and Unlock Procedures: Plan and execute final database locks, data freezes, and unlocks ensuring readiness for statistical analysis.
12. Data Archival and eTMF Interfaces: Oversee archival of trial data and metadata, ensuring alignment between CDM and TMF systems.
13. CDISC Standards and Submission Deliverables: Supervise mapping and quality control of SDTM/ADaM deliverables for eSubmission readiness.
14. AI-Assisted Review and Automation in CDM: Introduce AI and automation strategies to optimize validation, coding, reconciliation, and QC cycles.
15. Leadership and Team Management in Data Operations: Lead multi-study CDM teams, allocate resources, manage performance, and drive continuous process improvement.

Getting in Touch

For more information, please call us at +1 732.770.4100 / +1 732.207.4564 (WhatsApp) or email qpdc@qtech-solutions.com. Our course specialists will reach out to you promptly to assist you in taking the next steps toward your career goals.