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The Lotus Group LLC · 2 days ago

Lead Clinical Data Manager Consultant

United States

Contract

Remote

Senior Level, Lead/Staff

4+ years exp

The Lotus Group LLC is seeking a Lead Clinical Data Manager Consultant who will work closely with vendor Project Managers and Clinical Data Managers to ensure compliance with regulations and internal standards. This role involves leading data management activities for assigned studies and ensuring quality and readiness across the study lifecycle.

Life ScienceRecruitingStaffing Agency

Hiring Manager

Derek Reilly

Responsibilities

Serve as the primary Data Management point of contact for assigned studies, representing DM on cross-functional study teams and partnering with CROs responsible for data management deliverables

Lead and oversee clinical data management activities from study startup through database lock and archiving

Monitor CRO-led data cleaning activities and ensure data readiness for interim and final analyses

Coordinate key activities including medical coding, data validation checks, database snapshots, and data transfers

Prepare and communicate project status updates to study teams and leadership

Act as DM team lead to ensure databases are built, tested, validated, and ready for transfer and analysis in accordance with internal standards

Develop, maintain, and review study documentation including Data Management Plans/Manuals, CRF Completion Guidelines, validation specifications, and work instructions

Design, review, and modify CRFs as needed to support protocol requirements

Oversee database build, testing, validation, and post-production changes

Partner with study teams to coordinate internal and external data management functions and ensure adherence to processes and timelines

Support ongoing vendor relationships with a focus on data quality, efficiency, and standardization