Remote Clinical Operations Manager

Worldwide; North Carolina; Hybrid; USD 97,000 - 222,000; Full time

Benefits offered by this job

Competitive benefits package

Job summary

Worldwide Clinical Trials is seeking a Manager, Clinical Operations Site Management to lead a team of CRAs/IHCRAs, ensure training, onboarding, and ongoing performance across multiple studies. You will establish clear communication, review quality metrics, and manage resource allocation to meet project goals.

The role requires deep understanding of clinical research, FDA/ICH/HIPAA regulations, and hands-on experience with EDC systems like InForm and Medidata.

Qualifications

• Understanding of clinical research principles and data collection/editing.
• Knowledge of EDC software InForm and Medidata.
• Familiarity with FDA, ICH, and HIPAA regulations.
• Experience with SOPs and therapeutic area knowledge.

Responsibilities

• Manage and develop CRAs/IHCRAs, ensuring performance and onboarding.
• Provide on-site mentoring and regular communication with team.
• Monitor quality metrics like site visits, source data verification, and trial master file readiness.
• Review timecards and approve contractor hours.
• Conduct performance appraisals and implement CAPAs as needed.

Skills

Communication skills

Planning & organization

Interpersonal skills

Problem solving

Attention to detail

Clinical research knowledge

EDC software

FDA/ICH/HIPAA knowledge

SOPs knowledge

Therapeutic knowledge

MS Word/Excel/Outlook

Education

Bachelor's degree in biological/health sciences

Two-year college credential (or equivalent)

Experience as CRA/clinical research role

Tools

InForm

Medidata

Microsoft Word

Microsoft Excel

Microsoft Outlook

Job description

Worldwide Clinical Trials is seeking a Manager, Clinical Operations Site Management to lead a team of CRAs/IHCRAs, ensure training, onboarding, and ongoing performance across multiple studies. You will establish clear communication, review quality metrics, and manage resource allocation to meet project goals.

The role requires deep understanding of clinical research, FDA/ICH/HIPAA regulations, and hands-on experience with EDC systems like InForm and Medidata.