Clinical Assessment Ops Lead: Rater Training & Data

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

Job summary

Worldwide Clinical Trials is seeking an Operations Manager to oversee rater selection, training content, scale acquisition, surveillance, and document management for CAT projects. You will ensure SOP/ICH-GCP compliance and collaborate with the Operations Director and study teams.

You will coordinate rater qualifications, develop training portals, manage meetings, and supervise workflows, budgets, and staff to deliver on study timelines. Domestic and international travel may be required.

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 SOPs, ICH/GCP, and regulatory guidelines.
• Fluency in English.

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; manager 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.
• 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. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all‑inclusive.

Skills

Highly organized

Excellent planning

Meeting deadlines

Communication skills

Team collaboration

Time management

Self-motivation

Education

Bachelor's degree in Life Science

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Adobe

Job description

Worldwide Clinical Trials is seeking an Operations Manager to oversee rater selection, training content, scale acquisition, surveillance, and document management for CAT projects. You will ensure SOP/ICH-GCP compliance and collaborate with the Operations Director and study teams.

You will coordinate rater qualifications, develop training portals, manage meetings, and supervise workflows, budgets, and staff to deliver on study timelines. Domestic and international travel may be required.