The Lead Clinical Data Manager (LCDM) is responsible for overseeing the design, implementation, and maintenance of clinical data systems and processes (including change management) to ensure high-quality data collection and integrity across clinical trials. This role plays a critical part in driving innovation, ensuring compliance, and collaborating cross-functionally to support successful trial execution.
Key Responsibilities:
Data Management Leadership: Direct the development and maintenance of clinical trial databases for pharmaceutical and biologic compounds.
Data Integrity & Quality: Design and execute comprehensive edit checks to ensure data accuracy, consistency, and compliance with regulatory standards.
Discrepancy Resolution: Collaborate to resolve complex data discrepancies and ensure clean datasets.
Data Analysis & Reporting: Develop Data Validation Plan; partner with study teams to analyze data, troubleshoot issues, and communicate findings with investigator sites.
Process Innovation: Lead the implementation of paperless studies using Electronic Data Capture (EDC) systems and contribute to process optimization while reinforcing change management principles.
Stakeholder Collaboration: Work closely with clinical researchers, project managers, statisticians, and other stakeholders to meet project goals.
Operational Excellence:
 Implement Quality by Design (QbD) frameworks.
 Support enhanced Ways of Working (WoW) initiatives to promote first-time-right (FTR) execution.
 Define and track metrics to measure process improvements and outcomes.
 Align training strategies with the Zero Gravity program and develop Just-in-Time (JIT) training content.
 Execute study build and related process tasks in alignment with timelines and deliverables.
 Maintain documentation in accordance with Client SOPs and regulatory guidance.
 Respond to User Acceptance Testing (UAT) findings and implement corrective/preventive actions.
 Serve as the primary CDM point of contact for assigned studies and collaborate with Client Leads on strategy and process improvements.
Job Requirements:
This role requires hybrid onsite work at the client site in Southeastern PA or Northern NJ