Operations Manager - Clinical Assessment Technologies

Worldwide Clinical Trials; Baton Rouge (LA); On-site; USD 90,000 - 178,000; Full time

Job summary

Worldwide Clinical Trials seeks an Operations Manager to oversee rater selection, rater certification, rater training content, scale acquisition, surveillance maintenance, and workbook/source document management for Worldwide Clinical Trials, Inc. This role ensures all projects are conducted on time and compliant with SOPs, ICH/GCP, and regulatory guidelines.

Reporting to the Operations Director, Clinical Assessment Technologies, you will coordinate meetings, develop study-specific training

Qualifications

• Bachelor’s degree in Life Science preferred.
• 2–4 years clinical trials experience.
• 2+ years managing a team or leading a team.

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

Organizational skills

Detail-oriented

Planning

Communication skills

Team leadership

Project management

Time management

Education

Bachelor’s degree in Life Science

Tools

Microsoft Word

Excel

PowerPoint

Adobe

Job description

Worldwide Clinical Trials seeks an Operations Manager to oversee rater selection, rater certification, rater training content, scale acquisition, surveillance maintenance, and workbook/source document management for Worldwide Clinical Trials, Inc. This role ensures all projects are conducted on time and compliant with SOPs, ICH/GCP, and regulatory guidelines.

Reporting to the Operations Director, Clinical Assessment Technologies, you will coordinate meetings, develop study-specific training