Operations Lead, Clinical Assessment Technologies

Worldwide Clinical Trials; Denver (CO); 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, and study documentation for clinical assessments across Phase I-IV trials. You will ensure SOP/ICH-GCP compliance, coordinate meetings, and manage data surveillance and archiving while supporting budgetary needs and sponsor expectations.

The role requires strong organization, leadership, and communication skills, plus hands-on experience managing teams and delivering on timelines in a

Qualifications

• Bachelor’s degree in Life Science preferred.
• 2–4 years of experience in clinical trials.
• Experience managing a team for at least 2 years.
• Familiarity with SOPs, ICH/GCP and regulatory guidelines.

Responsibilities

• Coordinate completeness of rater experience qualification documents and communicate results to Sponsor and study team.
• Develop study-specific rater training web portals and ensure readiness based on study timelines.
• Coordinate Investigators’ Meetings logistics and CAT materials.
• Organize editing and formatting of didactic training presentations.
• Oversee scale licenses, translations, regulatory authorizations, and Sponsor approvals.
• Oversee data surveillance methodology maintenance and reporting.
• Provide CAT data for Final Study Report.
• Oversee archiving of CAT study documents.
• Consult on rater training and data surveillance plans.
• May develop and present at Sponsor Kick-Off Meetings regarding CAT operations.

Skills

Organization

Detail-oriented

Planning

Communication

Team leadership

Time management

MS Office

Education

Bachelor’s degree in Life Science

Tools

Microsoft Word

Microsoft Excel

Adobe

PowerPoint

Job description

Worldwide Clinical Trials is seeking an Operations Manager to oversee rater selection, training content, and study documentation for clinical assessments across Phase I-IV trials. You will ensure SOP/ICH-GCP compliance, coordinate meetings, and manage data surveillance and archiving while supporting budgetary needs and sponsor expectations.

The role requires strong organization, leadership, and communication skills, plus hands-on experience managing teams and delivering on timelines in a