Manager-Country Study Management-CMH

<p style="text-align:left">At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.</p><p style="text-align:inherit"></p><p>Country Study Manager<br /><br />Company:** Lilly Suzhou Pharmaceutical Co., Ltd.<br /><br />---<br /><br />Job Summary<br /><br />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.<br /><br />---<br /><br />Responsibilities<br /><br />* **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.<br />* **Study Planning &amp; 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.<br />* **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.<br />* **Budget and Resource Management:** Manage country-level study budgets, ensuring efficient allocation of resources and adherence to financial targets. Identify and resolve budget deviations.<br />* **Regulatory Compliance:** Ensure all clinical trial activities comply with local regulatory requirements (e.g., NMPA), ethical guidelines, and Lilly&#39;s Standard Operating Procedures (SOPs). Prepare and submit necessary regulatory documents.<br />* **Team Leadership &amp; 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.<br />* **Risk Management:** Proactively identify potential risks to study execution, develop mitigation strategies, and escalate issues to relevant stakeholders as appropriate.<br />* **Communication &amp; 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.<br />* **Quality Assurance:** Implement and maintain robust quality control processes to ensure data integrity and overall study quality. Participate in audits and inspections as required.<br /><br />---<br /><br />Qualifications<br /><br />* **Education:** Bachelor&#39;s degree in a scientific, healthcare, or related field (e.g., Pharmacy, Life Sciences, Nursing). A Master&#39;s degree is preferred.<br />* **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.<br />* **Clinical Knowledge:** Strong understanding of drug development processes, Good Clinical Practice (GCP), and relevant international and local regulatory requirements (e.g., NMPA regulations).<br />* **Project Management Skills:** Proven ability to manage complex projects, prioritize tasks, and meet deadlines in a fast-paced environment. PMP certification is a plus.<br />* **Leadership &amp; Communication:** Excellent leadership, communication (written and verbal), interpersonal, and negotiation skills. Ability to influence and motivate cross-functional teams.<br />* **Problem-Solving:** Demonstrated strong analytical and problem-solving abilities, with a proactive and solutions-oriented approach.<br />* **Language:** Fluency in Mandarin Chinese and English (both written and spoken) is required.<br />* **Technical Skills:** Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and clinical trial management systems.<br />* **Travel:** Ability to travel domestically and internationally as required (approximately 20-30%).</p><p></p><p>Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (<a href="https://careers.lilly.com/us/en/workplace-accommodation" target="_blank">https://careers.lilly.com/us/en/workplace-accommodation</a>) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.</p><p></p><p>Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.</p><p></p>#WeAreLilly