Manager, Clinical Operations, Site Management

🔥 0 minutes ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

💵 $97k - $222k / year

⏰ Full Time

🟠 Senior

🔴 Lead

🏥 Clinical Operations

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Worldwide Clinical Trials

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Worldwide Clinical Trials is a global contract research organization (CRO) that provides comprehensive clinical trial services. They specialize in supporting studies across diverse therapeutic areas such as oncology, cardiology, and rare diseases. With over 30 years of experience, Worldwide Clinical Trials emphasizes personalized support and customized solutions throughout the entire lifecycle of drug development. Their services include clinical monitoring, data management, patient recruitment, and regulatory consulting, ensuring precision and tailored attention for each clinical trial.

📋 Description

• Interview and select CRA/In-House Clinical Research Associate (IHCRA) candidates • Ensure consistent onboarding of permanent and contract CRAs/IHCRAs • Ensure CRAs are properly and timely trained to perform all types of visits and other billable monitoring activities • Provide on-site mentoring for CRAs through observation or site assessment visits • Establish regular communication and 1:1 calls with CRAs/IHCRAs to review quality metrics, including site visit report compliance, source data verification metrics, trial master file readiness, expense report submissions, and project status • Manage the quality of assigned CRAs/IHCRAs • Act as a point of escalation for CRA/IHCRA performance issues on projects • Review timecards, including hours billed by contractors • Review the accuracy of Sciforma assignments and workload • Conduct performance appraisals, reward and discipline employees, address employee relations issues, and resolve problems • Write and conduct corrective and preventive actions (CAPAs) when necessary; support Directors of Clinical Operations • Approve CRA/IHCRA paid time off requests • Review and approve CRA/IHCRA non-billable expenses

🎯 Requirements

• Four-year college curriculum with a major concentration in biological, physical, health, pharmacy, or other related sciences and six years of clinical research experience as a clinical research associate, OR • Two-year college curriculum (unless holding a nursing degree; then see requirement above) or equivalent education/training and seven years of clinical research experience as a clinical research associate, OR • Eight years of clinical research experience as a clinical research associate or in another position directly related to clinical research with a pharmaceutical or biotechnology company • Two years of management experience • Ability to understand multiple study protocols • Superior oral and written communication skills • Strong planning and organizational skills • Good interpersonal skills • Experienced problem-solving and decision-making skills • Strong attention to detail • Understanding of clinical research principles and processes, including data collection and editing skills • Ability to navigate Electronic Data Capture (EDC) software such as InForm and Medidata • Strong knowledge of U.S. Food and Drug Administration (FDA) regulations, International Council for Harmonisation (ICH) guidelines, and the Health Insurance Portability and Accountability Act (HIPAA) • Understanding of standard operating procedures • Knowledge of therapeutic areas • Knowledge of Microsoft Word, Excel, and Outlook • Travel required • Passport required

🏖️ Benefits

• Competitive benefits package depending on location • Paid time off (PTO) for CRA/IHCRA employees • Inclusive and equitable workplace • Transparent compensation and pay equity