Clinical Development Trial Lead

As a Clinical Development Trial Lead (CDTL) at Lilly, you will play a crucial role in leading study teams of internal and external partners to plan and execute studies within the clinical plan. Your primary responsibility will be to ensure the quality, on-time, and on-budget fulfillment of study deliverables. Additionally, you may support non-study project assignments aimed at transforming and improving the business. You will be expected to seek knowledge from internal and external sources to shape development plans and identify continuous improvement opportunities. **Key Responsibilities:** - **Project Management and Regional Operational Knowledge:** - Understand the scope of work required for successful completion of post-marketing studies/trials and make necessary changes as per the change control process. - Develop and track the enrollment plan by aligning inputs across functions and geographies. - Assess, identify, and monitor trial-level risks, incorporating scientific knowledge and regional expertise for risk mitigation. - Monitor trial-level budget components and network with business partners for budget status updates. - Coordinate and participate in affiliate, site, and investigator training. - Drive and coordinate cross-functional study teams throughout study implementation, execution, and closure. - Manage trial/regional enrollment strategy and execution. - Serve as a central owner for trial communication and manage relationships. - Identify and develop continuous improvement activities based on industry trends. - **Clinical Trial Process Leadership and Expertise:** - Demonstrate understanding of the drug development process and coordinate geographic and functional input for study teams. - Ensure inspection readiness of Trial Master File (TMF) records. - Anticipate trial and regional issues, propose proactive approaches for risk mitigation, and lead in ambiguous situations. - Report and interpret information for studies/trials across multiple business systems. - Apply knowledge of global/regional regulations and Good Clinical Practice (GCP) standards. - **Scientific Expertise:** - Provide technical consultation for clinical and regulatory documents. - Impact clinical trial design and feasibility through scientific, regional, and operational knowledge. - Support scientific needs of the business using critical thinking and problem-solving skills. **Qualification Required:** - **Basic Requirements:** - Bachelor's or University degree in a scientific or health-related field with 10 years of clinical research experience or relevant experience. - **Additional Preferences:** - Strong leadership, networking, and communication skills. - Demonstrated problem-solving abilities and self-management skills. - Proficiency in project management tools. - Previous experience in cross-functional teams or projects. - Ability to travel up to 10% depending on responsibilities. - Prior clinical trial site-level or affiliate experience. Lilly is committed to providing equal opportunities for individuals with disabilities in the workforce. If you need accommodation to apply for a position at Lilly, please complete the accommodation request form for further assistance.,