Manager, Clinical Assessment Technologies Operations

About This Role

This role involves overseeing the operational aspects of clinical assessment technologies, focusing on rater selection, certification, training content, scale acquisition, surveillance maintenance, and document management. The manager ensures that all assigned projects are completed on time and in compliance with SOPs, ICH/GCP, and regulatory guidelines, working under the direction of the Operations Director, Clinical Assessment Technologies.

Responsibilities

• Coordinate completeness of rater experience qualification documents and communicate collection results to the Sponsor and study team
• Develop study-specific rater training web portals and ensure readiness based on study timelines
• Coordinate logistical matters of the Investigators’ Meetings and associated CAT materials; may attend such meetings
• Organize the timely completion of editing and formatting of didactic training presentations
• Oversee scale and study source workbook management by obtaining scale licenses, translations, regulatory authorizations, and Sponsor approvals
• Oversee data surveillance methodology maintenance by tracking and reconciling incoming source documentation and providing reports to the study team and Sponsor
• Provide necessary CAT data to ensure comprehensiveness of CAT’s Final Study Report
• Oversee archiving of all CAT study documents
• Consult on rater training and data surveillance plans to ensure documents represent Sponsor and protocol specifications
• Perform other Clinical Assessment responsibilities
• May develop and present at Sponsor Kick-Off Meetings regarding CAT operations work
• Work with the Operations Director and Worldwide Clinical Trials study team to ensure study budgetary demands are met
• Manage Operations staff, as assigned
• Perform other duties as assigned

Requirements

• Highly organized, detail-oriented, and service-oriented
• Excellent planning, managing, and communication skills

About the Company

Worldwide Clinical Trials is a global, midsize CRO with over 3,500 experts dedicated to improving lives by taking pioneering, creative approaches to clinical research.