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Country Study Manager:

Company: Lilly Suzhou Pharmaceutical Co., Ltd.

Job Summary:

The Country Study Manager (CSM) at Lilly Suzhou Pharmaceutical Co., Ltd. is a critical leadership role responsible for the operational planning, execution, and oversight of clinical trials within China, ensuring adherence to global and local regulations, Lilly standards, and project timelines.

Responsibilities:

• *Clinical Trial Management: Lead and manage all operational aspects of assigned clinical studies within China, from study start-up to close-out, ensuring efficient execution and achievement of key milestones.
• *Study Planning & Strategy: Develop and implement country-specific operational plans, including site selection strategies, patient recruitment tactics, and risk mitigation plans, in alignment with global study objectives.
• *Vendor and Site Oversight: Oversee the performance of Contract Research Organizations (CROs), investigational sites, and other external vendors, ensuring compliance with protocols, GCP, and regulatory requirements. Conduct co-monitoring visits as needed.
• *Budget and Resource Management: Manage country-level study budgets, ensuring efficient allocation of resources and adherence to financial targets. Identify and resolve budget deviations.
• *Regulatory Compliance: Ensure all clinical trial activities comply with local regulatory requirements (e.g., NMPA), ethical guidelines, and Lilly's Standard Operating Procedures (SOPs). Prepare and submit necessary regulatory documents.
• *Team Leadership & Mentoring: Provide leadership, guidance, and mentorship to local study teams, including Clinical Research Associates (CRAs) and other study personnel. Foster a collaborative and high-performing team environment.
• *Risk Management: Proactively identify potential risks to study execution, develop mitigation strategies, and escalate issues to relevant stakeholders as appropriate.
• *Communication & Collaboration: Serve as the primary point of contact for global study teams regarding country-specific operational matters. Facilitate effective communication and collaboration with internal and external stakeholders.
• *Quality Assurance: Implement and maintain robust quality control processes to ensure data integrity and overall study quality. Participate in audits and inspections as required.

Qualifications:

• *Education: Bachelor's degree in a scientific, healthcare, or related field (e.g., Pharmacy, Life Sciences, Nursing). A Master's degree is preferred.
• *Experience: Minimum of 5 years of experience in clinical research, with at least 2 years in a clinical study management or leadership role within the pharmaceutical or biotechnology industry, preferably in China.
• *Clinical Knowledge: Strong understanding of drug development processes, Good Clinical Practice (GCP), and relevant international and local regulatory requirements (e.g., NMPA regulations).
• *Project Management Skills: Proven ability to manage complex projects, prioritize tasks, and meet deadlines in a fast-paced environment. PMP certification is a plus.
• *Leadership & Communication: Excellent leadership, communication (written and verbal), interpersonal, and negotiation skills. Ability to influence and motivate cross-functional teams.
• *Problem-Solving: Demonstrated strong analytical and problem-solving abilities, with a proactive and solutions-oriented approach.
• *Language: Fluency in Mandarin Chinese and English (both written and spoken) is required.
• *Technical Skills: Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and clinical trial management systems.
• *Travel: Ability to travel domestically and internationally as required (approximately 20-30%).

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