Clinical Assessment Operations Lead

Worldwide Clinical Trials; British Columbia; On-site; CAD 126,000 - 248,000; Full time

Job summary

Worldwide Clinical Trials is seeking an Operations Manager to oversee rater selection, certification, and training content, plus scale acquisition and source document management across global trials.

The role ensures projects run on time and in compliance with SOPs, ICH/GCP, and regulatory guidelines, reporting to the Operations Director and collaborating with the study team to meet timelines and budgets.

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.
• Demonstrable knowledge of SOPs, ICH/GCP, and regulatory guidelines.
• Fluency in English (will be required to write, speak, and understand English).
• Willingness to travel domestically and internationally.

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 Investigators’ Meetings and CAT materials; may attend such meetings.
• Organize timely editing and formatting of didactic training presentations.
• Oversee scale licenses, translations, regulatory authorizations, and Sponsor approvals.
• Oversee data surveillance methodology maintenance and reporting to the study team and Sponsor.
• Provide CAT data to ensure completeness of the Final Study Report.
• Oversee archiving of all CAT study documents.
• Consult on rater training and data surveillance plans to reflect Sponsor and protocol specs.
• May develop and present at Sponsor Kick-Off Meetings regarding CAT operations work.
• Work with the Operations Director and Worldwide study team to meet budgetary demands.
• Manage Operations staff, as assigned.
• Perform other duties as assigned.

Skills

Highly organized

Excellent planning

Time management

Strong writing skills

Verbal communication

Interpersonal skills

Team collaboration

Microsoft Word

Microsoft Excel

PowerPoint

Adobe proficiency

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, certification, and training content, plus scale acquisition and source document management across global trials.

The role ensures projects run on time and in compliance with SOPs, ICH/GCP, and regulatory guidelines, reporting to the Operations Director and collaborating with the study team to meet timelines and budgets.