Study Start-Up Lead

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🔥 0 minutes ago

🌐 China, Hong Kong, +2 more countries – Remote

🇨🇳 China – Remote 🇭🇰 Hong Kong – Remote 🇲🇾 Malaysia – Remote 🇹🇼 Taiwan – Remote

⏰ Full Time

🟠 Senior

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Emerald Clinical

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2000

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Emerald Clinical is a leading global clinical research organization (CRO) founded in the Asia‑Pacific region that provides end‑to‑end clinical trial services to biopharmaceutical, medical device, and diagnostic companies. With about 25 years of experience and a team of 800+ operating across 40+ locations worldwide, Emerald Clinical manages trials across all phases including registration and post‑marketing studies, and offers clinical operations, project management, and trial staffing support. The company emphasizes scientific expertise, operational excellence, and global reach to support drug and device development.

📋 Description

• Lead and coordinate country-level study start-up activities to meet sponsor timelines and regulatory requirements • Develop and manage study start-up plans, forecasts, and deliverables • Oversee IRB/EC and hospital submissions, amendments, and issue resolution • Negotiate investigator budgets and contracts in collaboration with the Contracts Lead • Manage essential document collection and ensure compliance with local regulations and ICH-GCP • Support global TMF readiness and document quality during the start-up phase • Act as the central liaison between internal teams, sponsors, and investigative sites • Lead and support continuous improvement initiatives within the SSU function

🎯 Requirements

• Bachelor’s degree in life sciences or a health-related field • Minimum 5 years of clinical research experience • At least 2 years of experience in study start-up or regulatory submissions • CTIS experience • Strong understanding of global and local regulatory requirements • Experience negotiating site contracts and budgets • Excellent organizational and communication skills • Ability to work independently and collaborate across global teams • Experience in CRO or pharma environments strongly preferred • Mandarin fluency preferred

🏖️ Benefits

• Purpose-driven work contributing to clinical trials in renal, cardiometabolic, and oncology therapies • Collaboration with global teams and diverse perspectives • Competitive salary and benefits package tailored to skills and experience • Hybrid or remote working arrangements, depending on location and role • Learning opportunities and access to a global network of scientific leaders • Employee wellbeing programs supporting work-life balance, health, and team connection • Global engagement surveys • Recognition programs • Team-building events • Exposure to diverse international projects and clients