Operations Lead, Clinical Assessment Technologies

Worldwide Clinical Trials; Augusta (ME); On-site; USD 90,000 - 178,000; Full time

Job summary

Worldwide Clinical Trials in the United States is seeking an Operations Manager to oversee rater selection, certification, training content, scale acquisition, surveillance, and workbook management for CAT programs.

You will ensure SOP/ICH-GCP compliance, manage a team, coordinate sponsor meetings, and support study budgets. Domestic and international travel is required; a detail-oriented, organized, and collaborative approach is essential.

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.
• Competency with data and numbers.
• Fluency in English (write, speak, understand).
• Willingness to travel domestically and internationally.

Responsibilities

• Coordinate completeness of rater experience qualification documents and communicate results to Sponsor and study team.
• Develop study-specific rater training portals and ensure readiness based on timelines.
• Coordinate Investigators’ Meetings and CAT materials; may attend.
• Lead editing and formatting of didactic training presentations.
• Oversee scale licenses, translations, regulatory authorizations, and Sponsor approvals.
• Monitor data surveillance and provide reports to study team and Sponsor.
• Provide CAT data to ensure comprehensiveness of Final Study Report.
• Archive CAT study documents.
• Advise on rater training and data surveillance plans.
• May present at Sponsor Kick-Off meetings on CAT operations.
• Support study budgets and collaborate with Worldwide study team.
• Manage Operations staff as assigned.

Skills

Organizational skills

Project management

Time management

Communication

Education

Bachelor’s degree in Life Science

Tools

Microsoft Office

Job description

Worldwide Clinical Trials in the United States is seeking an Operations Manager to oversee rater selection, certification, training content, scale acquisition, surveillance, and workbook management for CAT programs.

You will ensure SOP/ICH-GCP compliance, manage a team, coordinate sponsor meetings, and support study budgets. Domestic and international travel is required; a detail-oriented, organized, and collaborative approach is essential.