Clinical Assessment Tech Ops Leader

Worldwide Clinical Trials

Annapolis (MD)

On-site

USD 90,000 - 178,000

Full time

5 days ago
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Job summary

Worldwide Clinical Trials is seeking an Operations Manager to oversee rater selection, training content, scale management, and data surveillance for clinical assessments. You will ensure SOP/ICH-GCP compliance, lead the CAT operations team, and support study budgets while coordinating with the Operations Director.

The role requires strong organizational, planning, and communication skills, with travel to meetings and global stakeholders. A Life Science degree and trial experience are essential.

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.
  • Solid knowledge of SOPs, ICH/GCP, and regulatory guidelines.
  • Fluency in English and ability to write, speak, and understand 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 investigations meetings and CAT materials; may attend.
  • Oversee editing and formatting of didactic training presentations.
  • Manage scale licenses, translations, regulatory authorizations, and Sponsor approvals.
  • Maintain data surveillance methodology and generate reports for study team and Sponsor.
  • Provide CAT data to ensure comprehensiveness of Final Study Report.
  • Archive all CAT study documents.
  • Advise on rater training and data surveillance plans per sponsor specs.
  • May present at Sponsor Kick-Off meetings regarding CAT operations.
  • Assist with study budgets and ensure budgetary demands are met.
  • Supervise Operations staff as assigned.

Skills

Organized
Planning
Timelines
Communication
Interpersonal skills
Multitasking
Self-motivation
Teamwork
MS Office

Education

Bachelor's degree in Life Science

Tools

MS Word
MS Excel
Adobe
PowerPoint

Job description

Worldwide Clinical Trials is seeking an Operations Manager to oversee rater selection, training content, scale management, and data surveillance for clinical assessments. You will ensure SOP/ICH-GCP compliance, lead the CAT operations team, and support study budgets while coordinating with the Operations Director.

The role requires strong organizational, planning, and communication skills, with travel to meetings and global stakeholders. A Life Science degree and trial experience are essential.

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