Operations Lead – Clinical Assessment Technologies

Worldwide Clinical Trials; New Mexico; On-site; USD 90,000 - 178,000; Full time

Job summary

Worldwide Clinical Trials is seeking an experienced Operations Manager to oversee rater selection, training content, scale acquisition, surveillance maintenance, and document management for CAT projects. You’ll ensure timely, SOP- and ICH/GCP-compliant execution across studies in a global framework.

You will lead cross-functional teams, manage budgets, coordinate sponsor communications, and drive quality in study deliverables while traveling as needed to meet stakeholder needs.

Qualifications

• Bachelor’s degree in Life Science preferred.
• Two to four years of experience in clinical trials.
• At least two years of experience managing or leading a team.
• Knowledge of Phase I–IV clinical trials, SOPs, ICH/GCP, and regulatory guidelines.
• Strong numerical/data-handling skills.
• Fluency in English (written and spoken).

Responsibilities

• Coordinate completeness of rater experience qualification documents and communicate 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 Investigators’ Meetings and CAT materials; 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 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 reflect Sponsor/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.

Skills

Organizational skills

Detail-oriented

Service orientation

Planning & scheduling

Deadline-driven

Written & verbal communication

Interpersonal skills

MS Office proficiency

Education

Bachelor’s degree in Life Science

Job description

Worldwide Clinical Trials is seeking an experienced Operations Manager to oversee rater selection, training content, scale acquisition, surveillance maintenance, and document management for CAT projects. You’ll ensure timely, SOP- and ICH/GCP-compliant execution across studies in a global framework.

You will lead cross-functional teams, manage budgets, coordinate sponsor communications, and drive quality in study deliverables while traveling as needed to meet stakeholder needs.