Associate Director/Clinical Data Management - Twin Image Recruiting

Position Description

The Associate Director of Clinical Data Management (CDM) is an integral member of the Research and Development (R&D) organization who supports all Clinical Data Management aspects of strategic planning and execution in accordance with corporate standard operating procedures (SOP), GCP, 21 CFR, and ICH guidance. Key responsibilities:

Ensure analysis-ready, clean databases which accurately reflect study conduct, support the submission of regulatory dossiers (IND, NDA, sNDA, CTD) and scientific publications for phase I, II, IIb, III, and IV clinical trials.
Manage and mentor CDM personnel assigned to project or departmental team
Assist Director of CDM in ensuring appropriate CDM internal resources are applied to all clinical trials by recruiting, mentoring, and retaining industry best professionals to manage oversight of CDM activities
Assist Director of CDM by acting as liaison with Clinical Research, Medical Affairs, Clinical Pharmacology, and Clinical Operations to provide technical expertise in data planning, retrieval, and reporting
Assist Director of CDM in the management, production and distribution of CDM metrics reports to the project teams and senior management
Assist Director of CDM and Training Manager in the development of SOPs, BPs & WPs that facilitate CDM project management and ensure quality.
Requirements:
· Bachelor’s degree in biology, allied health, nursing, or related life science

· Minimum 10 years experience in clinical data management in the pharmaceutical industry

· Knowledge of regulations related to Data Management and clinical research such as GCP, ICH Guidance, 21 CFR

How to Apply

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