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IQVIA स्वास्थ्य सेवा डेटा विश्लेषण, उन्नत तकनीक और परामर्श सेवाओं को एकीकृत करके जीवन विज्ञान और स्वास्थ्य सेवा क्षेत्रों में संगठनों को जटिल चुनौतियों का समाधान करने में सहायता करती है। इसका कनेक्टेड इंटेलिजेंस प्लेटफ़ॉर्म डेटा और कृत्रिम बुद्धिमत्ता को एक साथ लाकर नैदानिक अनुसंधान, प्रौद्योगिकी विकास और नई उपचार पद्धतियों को आगे बढ़ाने में सहयोग करता है। कंपनी की टीमें विश्लेषण, परामर्श और स्वास्थ्य सेवा प्रौद्योगिकी के क्षेत्रों में काम करती हैं, जिससे अनुसंधान, डिजिटल नवाचार और रोगियों के बेहतर परिणामों से जुड़े अवसर मिलते हैं।
Senior Clinical Trial Manager, Oncology — Durham, NC (Onsite)
Lead country-level operations for complex oncology clinical trials at IQVIA in Durham, coordinating sites, vendors, recruitment, compliance, budgets, and patient safety. The role serves as the primary sponsor contact and operational lead for high-priority or high-risk studies.
विवरण
- Follow sponsor SOPs, work instructions, policies, GCP standards, and applicable local regulations
- Provide subject-matter guidance on study quality and compliance requirements
- Lead or support site selection, feasibility, qualification visits, and performance improvement
- Coordinate local teams, recruitment plans, risk management, contingency actions, budget forecasts, and mitigation strategies
- Serve as the primary sponsor contact and local operational lead for assigned complex studies
- Maintain trial management systems and assess study progress, risks, trends, and issues
- Launch corrective and preventive actions when studies diverge from plan
- Create and implement country-level recruitment and contingency strategies
- Oversee country-level vendors, performance issues, budgets, invoices, and study supplies
- Lead local trial meetings and support Site Manager training
- Prepare and maintain country- and site-specific informed consent materials
- Ensure adverse events and patient safety issues are reported and escalated correctly
- Maintain inspection readiness, complete trial data, and essential records in CTMS and eTMF/IF systems
- Monitor site data quality, query resolution, operational performance, and CAPA execution
- Manage local trial budgets, financial reporting, forecasting, and mitigation plans
- Coordinate IEC and health authority approvals and advise on regulatory requirements
- Train, mentor, and coach less experienced colleagues
- Lead process improvement, operational excellence, inspection readiness, and new system implementation efforts
- Direct country-level planning and execution for complex, high-priority, or high-risk studies
आवश्यकताएँ
- Bachelor’s degree
- Degree in a health- or science-related discipline
- Three to five or more years of trial management experience, including independent management of complex clinical trials and country-level execution leadership
- Experience in oncology
- Strong knowledge of ICH-GCP, sponsor SOPs, local laws and regulations, assigned protocols, and related protocol procedures
- Strong proficiency with relevant software and sponsor systems
- Availability for business travel, including occasional overnight stays
- Professional fluency in the country language and English, both spoken and written
- Clear written and verbal communication skills
लाभ
- Incentive plans, bonuses, and/or other compensation may be available
- Health and welfare benefits may be available
- Occasional overnight travel may be required based on business needs
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