ICON plc स्वास्थ्य सेवा और फार्मास्युटिकल उद्योगों को सेवाएँ प्रदान करने वाला एक वैश्विक कॉन्ट्रैक्ट रिसर्च संगठन है। इसका कार्य क्लिनिकल, परामर्श और वाणिज्यिक सेवाओं तक फैला है, जो शुरुआती अनुसंधान से लेकर विपणन-पश्चात गतिविधियों तक दवा विकास में सहायता करती हैं। कंपनी विकेंद्रीकृत क्लिनिकल परीक्षण, हृदय सुरक्षा, प्रारंभिक क्लिनिकल प्रयोगशालाएँ, मेडिकल इमेजिंग, नियामक इंटेलिजेंस और वास्तविक-विश्व साक्ष्य जैसी सेवाएँ प्रदान करती है। ICON plc हृदय रोग, ऑन्कोलॉजी, आंतरिक चिकित्सा, सेल और जीन थेरेपी तथा बायोसिमिलर जैसे क्षेत्रों में चिकित्सीय विशेषज्ञता भी उपलब्ध कराती है। डेटा विश्लेषण और रोगी-केंद्रित दृष्टिकोणों को मिलाकर कंपनी क्लिनिकल कार्यक्रमों को आगे बढ़ाने में मदद करती है।
Senior Clinical Trial Manager (Remote, Pennsylvania)
Lead clinical trial delivery for ICON, overseeing study start-up, execution, compliance, risk management, budgets, and closeout. Partner with sponsors and study teams to deliver high-quality research programs.
विवरण
- Manage assigned clinical trials from operational planning through delivery, meeting milestones, timelines, budget expectations, and quality standards.
- Coordinate study start-up, site activation, enrollment planning, and execution through database lock.
- Monitor study progress, monitoring activities, clinical metrics, and site performance.
- Create and implement study oversight plans, monitoring strategies, and risk mitigation measures.
- Resolve operational issues proactively to keep studies on track for successful delivery.
- Maintain effective working relationships with sponsors, investigators, vendors, and cross-functional stakeholders.
- Evaluate study performance metrics and deliver regular status reports and updates.
- Support, mentor, and collaborate with Clinical Research Associates and other study team members.
- Ensure trial activities meet protocol requirements, ICH-GCP guidelines, and applicable regulations.
आवश्यकताएँ
- Bachelor’s degree in life sciences, health sciences, nursing, pharmacy, or another relevant scientific discipline, or an equivalent combination of education and experience.
- Substantial clinical trial management experience in a CRO, pharmaceutical, or biotechnology setting, with CRO experience preferred.
- Track record of leading and delivering clinical studies from start-up through closeout.
- Strong knowledge of clinical trial operations, ICH-GCP, and relevant regulatory requirements.
- Experience overseeing study timelines, budgets, vendors, and cross-functional stakeholders.
- Ability to assess risks, resolve complex operational issues, and drive study execution.
- Previous clinical trial monitoring experience preferred.
- Experience with global and/or complex clinical trials preferred.
- Willingness and ability to travel up to 20%.
- Legal authorization to work in the country where the position is based.
लाभ
- Competitive base pay with performance-related incentives.
- Health and wellbeing programs, including medical, dental, and vision coverage where applicable.
- Retirement and pension plans.
- Life assurance and disability coverage.
- Employee assistance programs and wellbeing resources.
- Structured training and career development opportunities.