Clinical Operations Systems Manager
Responsible for managing the implementation, design and maintenance of clinical information systems including a Clinical Trial Management System (CTMS) and Electronic Trial Master File (eTMF) and Electronic Document Management System (EDMS) used to improve clinical operations. Responsible for establishing processes and training documents to support clinical information systems.
ESSENTIAL DUTIES AND RESPONSIBILITIES include, but are not limited to:
Managing projects with Information Technology (IT) in order to ensure effective integration of clinical systems.
Provide operational leadership, support, and maintenance for CTMS.
Managing the CTMS aspects of operational activities to support planning, initiation, conduct and close out phases of clinical studies.
Developing SOPs, process documents, training materials to support clinical information systems.
Supporting Clinical Operations Directors and study teams with study set up, maintenance, and reporting in clinical information systems.
Ensuring clinical study activities are conducted in compliance with FDA regulations, ICH guidelines, and NBI SOPs.
Leading new clinical operations initiatives to help streamline and standardize processes.
Performing other study management duties as needed on assigned clinical studies.
Requires detailed knowledge of clinical drug development process including working knowledge of ICH, GCPs, and FDA regulations. Clinical study management experience across all phases of clinical studies. Strong computer/IT skills, organizational skills, interpersonal and team participation skills are essential. Must possess appropriate skills for internal and external presentations. Effectively operate in multi-level matrix environment.
EDUCATION and/or EXPERIENCE:
BS, MS, or RN with a minimum of 5 years clinical operations with CTMS or clinical information systems experience in pharmaceutical industry/ Biotech or CRO. In some cases, a combination of education and prior directly related experience may be considered as equivalent.