Operations Leader, Clinical Assessment Technologies

Worldwide Clinical Trials

Cheyenne (WY)

On-site

USD 90,000 - 178,000

Full time

4 days ago
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Job summary

Worldwide Clinical Trials is seeking an Operations Manager to oversee rater selection, certification, training content, scale acquisition, surveillance, and workbook management for CAT operations. You will ensure projects align with SOPs, ICH/GCP, and regulatory guidelines, under the direction of the Operations Director, Clinical Assessment Technologies.

In this role you will coordinate training portals, manage study meetings, edit training materials, and monitor data surveillance and reports.

Qualifications

  • Bachelor’s degree in Life Science preferred.
  • Two to four years of experience in clinical trials.
  • At least two years in team leadership or demonstrated leadership and project management.
  • Strong knowledge of SOPs, ICH/GCP, and regulatory guidelines.
  • Fluency in English for day-to-day business.

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 Investigators’ Meetings and related CAT materials; attend meetings as needed.
  • Oversee editing and formatting of didactic training presentations.
  • Oversee 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 and archiving of study documents.
  • Advise on rater training and data surveillance plans to reflect Sponsor and protocol specs.
  • Support Sponsor Kick-Off Meetings for CAT operations and collaborate with study team on budgetary needs.
  • Manage Operations staff as assigned.

Skills

Organized
Detail-oriented
Planning
Time management
Communication
Team leadership
Interpersonal skills
MS Office

Education

Bachelor’s degree in Life Science

Tools

MS Word
Excel
Adobe
PowerPoint

Job description

Worldwide Clinical Trials is seeking an Operations Manager to oversee rater selection, certification, training content, scale acquisition, surveillance, and workbook management for CAT operations. You will ensure projects align with SOPs, ICH/GCP, and regulatory guidelines, under the direction of the Operations Director, Clinical Assessment Technologies.

In this role you will coordinate training portals, manage study meetings, edit training materials, and monitor data surveillance and reports.

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