Operations Lead, Clinical Assessment Technologies

Worldwide Clinical Trials; Saint Paul (MN); On-site; USD 90,000 - 178,000; Full time

Job summary

Worldwide Clinical Trials is seeking an Operations Manager to oversee rater selection, certification, training, scale acquisition, surveillance, and document management. You will ensure timely, compliant project execution under SOPs, ICH/GCP, and regulatory guidelines.

The role requires coordinating meetings, managing training materials, and leading CAT operations to support clinical assessments for Phase I–IV trials. Domestic and international travel is expected.

Qualifications

• Bachelor’s degree in Life Science preferred.
• Two to four years of experience working in clinical trials.
• At least two years of experience managing team members or leading a team.
• Demonstrable knowledge of SOPs, ICH/GCP, and regulatory guidelines.
• Fluency in English.
• Role requires domestic and international travel.

Responsibilities

• Coordinate completeness of rater experience qualification documents and report results to Sponsor and study team.
• Develop study-specific rater training web portals and ensure readiness based on study timelines.
• Coordinate logistical matters of Investigators’ Meetings and CAT materials; attend meetings if needed.
• Organize editing and formatting of didactic training presentations for timely delivery.
• Oversee scale licenses, translations, regulatory authorizations, and Sponsor approvals for study documents.
• Maintain data surveillance methodology and provide reports to study team and Sponsor.
• Provide CAT data to ensure comprehensiveness of Final Study Report.
• Oversee archiving of all CAT study documents.
• Advise on rater training and data surveillance plans per Sponsor and protocol.

Skills

Highly organized

Detail-oriented

Strong writing skills

Verbal communication

Microsoft Office proficiency

Team leadership

Time management

Data analysis

Education

Bachelor’s degree in Life Science

Tools

Microsoft Word

Excel

PowerPoint

Adobe

Job description

Worldwide Clinical Trials is seeking an Operations Manager to oversee rater selection, certification, training, scale acquisition, surveillance, and document management. You will ensure timely, compliant project execution under SOPs, ICH/GCP, and regulatory guidelines.

The role requires coordinating meetings, managing training materials, and leading CAT operations to support clinical assessments for Phase I–IV trials. Domestic and international travel is expected.