Associate Manager, Clinical Operations Site Management

🔥 0 minutes ago

🌐 Italy, Serbia, +1 more countries – Remote

🇮🇹 Italy – Remote 🇷🇸 Serbia – Remote 🇪🇸 Spain – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🏥 Clinical Operations

👻 Ghost score 10%

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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/IHCRA candidates • Ensure consistent onboarding of permanent and contract CRAs/IHCRAs • Ensure CRAs are properly and timely trained for all visit types and other billable monitoring activities • Provide on-site mentoring through observation or site assessment visits • Establish regular communication and 1:1 calls with CRAs/IHCRAs to review quality metrics, compliance, TMF readiness, expenses and project status • Act as escalation point for CRA/IHCRA performance issues • Review time cards and approve contractor hours billed • Review Sciforma assignments and workload accuracy • Conduct performance appraisals and address employee relations issues • Write and conduct CAPAs when necessary • Support Directors of Clinical Operations • Approve CRA/IHCRA PTO requests • Review and approve non-billable expenses

🎯 Requirements

• Ability to understand multiple study protocols • Superior oral and written communication skills • Strong planning and organizational skills • Good interpersonal skills • Experienced problem solving/decision making skills • Good attention to detail • Understanding of clinical research principles and processes • Data collection and editing skills • Ability to navigate EDC software (InForm, Medidata, etc.) • Strong knowledge of FDA regulations, ICH Guidelines and HIPAA • Understanding of standard operating procedures • Knowledge of therapeutic areas • Knowledge of Word, Excel and Outlook • Four-year college curriculum with a major concentration in biological, physical, health, pharmacy or other related science and six years clinical research experience as a clinical research associate, OR two-year college curriculum (unless nursing degree then see requirement above) or equivalent education/training and seven years clinical research experience as a clinical research associate, OR eight years of clinical research experience as a clinical research associate or other position directly related to clinical research with a pharmaceutical or biotechnology company • Travel required • Valid passport required

🏖️ Benefits

• Equal employment opportunities • Diverse and inclusive work environment • Supportive, team-oriented atmosphere • Hands-on, accessible leadership • Opportunities to collaborate with colleagues across diverse backgrounds and specialties • Employee PTO (approval of CRA/IHCRA PTO requests)