Clinical Assessment Technologies Operations Manager

About the role

The Operations Manager leads the operational activities related to rater selection, certification, training content, scale acquisition, data surveillance, and document management for Worldwide Clinical Trials. Reporting to the Operations Director of Clinical Assessment Technologies, the role ensures projects are delivered on time and comply with SOPs, ICH/GCP, and regulatory standards.

Key responsibilities

• Coordinate collection and communication of rater qualification documents to sponsors and study teams.
• Develop and maintain study‑specific rater training web portals, ensuring readiness according to study timelines.
• Manage logistical aspects of investigators’ meetings and related CAT materials.
• Oversee editing and formatting of didactic training presentations.
• Obtain scale licenses, manage translations, secure regulatory authorizations, and obtain sponsor approvals for study source workbooks.
• Maintain data surveillance methodology, track incoming source documentation, and provide reports to study teams and sponsors.
• Supply necessary CAT data for comprehensive final study reports.
• Oversee archiving of all CAT study documents.
• Consult on rater training and data surveillance plans to align with sponsor and protocol specifications.

Required profile

• Proven experience managing operational tasks in clinical assessment or CRO environments.
• Strong understanding of SOPs, ICH/GCP, and regulatory guidelines.
• Ability to coordinate multiple projects, meet deadlines, and communicate effectively with sponsors and internal teams.

Required skills