📘 Introduction

Lead Clinical Data Managers oversee end-to-end data operations across global trials— from protocol review and eCRF design to database lock and submission readiness—while leading teams, governing quality, and coordinating vendors and cross-functional stakeholders.

🧭 Course Overview

• 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

6 weeks (110 hours) • Self-Paced Online with Support (narrated lessons, readings, quizzes, and role-based tasks)

🎯 Leading CDM Operations – Live Webinar

Walk through a lead’s playbook: build governance, risk & issue management, metrics, and inspection readiness. Includes examples of dashboards, KPIs, and cross‑functional alignment, plus live Q&A.

• Study build oversight, UAT planning, and change control
• Risk‑based data review, issue logs, and CAPA leadership
• Stakeholder communication with Biostats, PV, QA, and Reg

✅ Key Learning Objectives

• Lead end‑to‑end CDM delivery from start‑up to DBL
• Oversee database design, setup, and validation (EDC, CRFs, edit checks)
• Guide team/project management for CDM deliverables and timelines
• Run risk assessments, resource planning, and cross‑functional coordination
• Ensure compliance with ICH‑GCP, FDA/EMA, and 21 CFR Part 11
• Lead DBL readiness, controlled unlocks, and submission deliverables
• Develop leadership, communication, and vendor management skills

🎯 Benefits & Outcomes

• Strategic leadership capability across multi‑study/global portfolios
• Stronger compliance and inspection readiness
• Confidence in vendor governance and stakeholder alignment
• Career readiness for roles such as CDM Lead, Data Operations Manager, or Associate Director

💼 Career Pathways

• Lead Clinical Data Manager (LCDM)
• Senior CDM / CDM Lead
• Clinical Data Operations Manager
• Associate Director, Data Management
• Head of Clinical Data Management

📚 Curriculum & Modules

• Role & Responsibilities of a Lead Clinical Data Manager
• Advanced Database Design & CRF/eCRF Oversight
• Edit Check Strategy & Validation Planning
• Study‑Level Query & Discrepancy Management
• Project & Team Management Skills
• Vendor Oversight & Collaboration in Outsourced Trials
• Risk Management & Mitigation in Data Operations
• Data Standards (CDISC SDTM, ADaM, Define.xml) for Submissions
• Audit & Inspection Readiness for CDM Leads
• DBL Leadership & Unlock Strategies
• Case Studies – Leading Global Trials in Pharma & CROs

💰 Tuition and Payment Methods

Tuition Fee: Refer to Tuition & Payment during application.

• Credit/Debit Card (Visa or Mastercard)
• Bank Transfer (ACH/Wire)
• Installment plan available
• Eligible promotions may apply

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