Clinical Trial Specialist, APAC (Mandarin Speaking)
Emerald Clinical
Support Emerald Clinical’s global early-phase trials across APAC. Coordinate study records, meetings, budgets, vendors, and trial master file activities.
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Regeneron एक जैव-प्रौद्योगिकी कंपनी है जो गंभीर और उपेक्षित स्वास्थ्य समस्याओं के लिए दवाओं की खोज, विकास और व्यावसायीकरण करती है। इसका अनुसंधान एलर्जी, हृदय एवं चयापचय संबंधी रोगों, तंत्रिका-विज्ञान, कैंसर-विज्ञान, रक्त-विज्ञान, नेत्र-विज्ञान और दुर्लभ रोगों तक फैला हुआ है। जैविक अनुसंधान को उन्नत प्रौद्योगिकी के साथ जोड़कर Regeneron जटिल स्वास्थ्य देखभाल आवश्यकताओं को पूरा करने के उद्देश्य से जैविक और आनुवंशिक औषधियों पर काम करती है। रोगी देखभाल को आगे बढ़ाने के अपने व्यापक मिशन के तहत कंपनी स्वास्थ्य समानता, पर्यावरणीय जिम्मेदारी, वैज्ञानिक शिक्षा और नैतिक कॉर्पोरेट प्रथाओं पर भी जोर देती है।
Associate Director, Data Validation Strategy — Regeneron Hybrid
Lead Regeneron’s clinical data validation and integrated data review strategy in a hybrid Associate Director role. Drive inspection-ready quality, risk-based review, analytics, and team development.
संयुक्त राज्य
न्यू जर्सी
न्यूयॉर्क$1,57,200 – $2,56,600 / वर्ष
हाइब्रिडपूर्णकालिकवरिष्ठआवश्यक भाषा: अंग्रेज़ीनिदेशकविवरण
- Own the implementation and delivery of the Integrated Data Review strategy, operating model, standards, and governance.
- Oversee Data Review Plan development, execution, quality, issue tracking, escalation, and resolution.
- Partner with Biostatistics, QISS, Clinical Data Reporting, and study teams on risk-based reviews aligned with critical-to-quality factors.
- Use KPIs and quality metrics to monitor performance, identify trends, and advance continuous improvement.
- Help create SOPs, work instructions, templates, and training resources for Integrated Data Review activities.
- Lead training, coaching, and change management to increase adoption across clinical and external data domains.
- Advance innovation, automation, and AI-enabled analytics initiatives.
- Manage, mentor, and develop the Integrated Data Review and Quality team.
- Work cross-functionally with Clinical Data Management, Biostatistics, Clinical Data Reporting, QISS, and study teams.
आवश्यकताएँ
- Bachelor’s degree in life sciences, statistics, computer science, or a related discipline.
- At least 10 years of Clinical Data Management experience in biotechnology, pharmaceuticals, or healthcare.
- At least 5 years of experience leading people, teams, and projects.
- Experience implementing integrated data review, quality management, risk-based data management, or centralized review processes.
- Strong knowledge of ICH E6 (R3), ICH E8 (R1), GxP, 21 CFR Part 11, and RBDM/RBQM principles.
- Experience supporting inspection-readiness activities.
- Experience using data review, visualization, and analytics tools to identify issues proactively.
- Willingness to work primarily on site with hybrid flexibility.
- Ability to travel up to 25%.
लाभ
- Hybrid work flexibility.
- Annual bonuses or other incentive opportunities.
- Equity awards.
- Pension or retirement benefits.
- 401(k) company matching.
- Health and wellness programs.
- On-site fitness centers.
- Medical, dental, vision, life, and disability insurance.
- Paid time off.
- Family support benefits.
- Reasonable recruitment-process accommodations where required.
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