Operations Lead, Clinical Assessment Technologies

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

Job summary

Worldwide Clinical Trials seeks an Operations Manager to oversee rater selection, certification, training content, scale acquisition and surveillance, ensuring SOP/ICH/GCP compliance. You will coordinate meetings, manage documentation, and guide CAT operations with the study team and Sponsor.

The role requires strong leadership, planning, and communication in a global setting. The position emphasizes budget alignment, archiving, and ensuring timelines are met across domestic and international

Qualifications

• Bachelor’s degree in Life Science preferred.
• 2–4 years experience in clinical trials.
• At least two years experience managing a team or leading a team.
• Strong knowledge of SOPs, ICH/GCP, and regulatory guidelines.
• Fluency in English (written and spoken).
• 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 study timelines.
• Coordinate logistics of Investigators’ Meetings and CAT materials; may attend meetings.
• Oversee editing and formatting of didactic training presentations.
• Manage scale licenses, translations, regulatory authorizations, and Sponsor approvals.
• Maintain data surveillance methodology and provide reports to study team and Sponsor.
• Provide CAT data for final study report completeness.
• Archive all CAT study documents.
• Advise on rater training and data surveillance plans.

Skills

Highly organised

Detail-oriented

Time management

Project management

Written & verbal communication

Interpersonal skills

MS Office proficiency

Education

Bachelor’s degree in Life Science

Tools

Microsoft Word

Excel

Adobe

PowerPoint

Job description

Worldwide Clinical Trials seeks an Operations Manager to oversee rater selection, certification, training content, scale acquisition and surveillance, ensuring SOP/ICH/GCP compliance. You will coordinate meetings, manage documentation, and guide CAT operations with the study team and Sponsor.

The role requires strong leadership, planning, and communication in a global setting. The position emphasizes budget alignment, archiving, and ensuring timelines are met across domestic and international