Director, Clinical Operations
Abarca HealthFull Time
Senior (5 to 8 years)
The Associate Director of Central Clinical Services requires a passion for implementing clinical capabilities such as mobile health care, telemedicine, virtual trial orchestration, recruitment & retention, new site models, central services, and digital devices. This role also necessitates strong vendor management skills. A deep understanding of local regulations, laws, guidance (e.g., FDA, ICH), Quality and Business Systems, and Good Clinical Practices (GCP) is essential for achieving inspection readiness and resolving quality issues. The ability to apply problem-solving skills and effectively partner with institutions, investigators, and cross-functional study teams is also a key requirement.
The Associate Director will be responsible for ensuring vendors deliver education, lead studies, and partner screening and consenting. They will supervise vendors in initiating and handling assessment scheduling, logistics, technology, and communication for various study-related entities. Responsibilities include ensuring vendors maintain study documentation and data entry, contributing to process optimization, and making decisions that impact operations in the best interest of participants and stakeholders. This role involves supervising vendor day-to-day operations, providing mentorship and training, and offering expertise in budget processes for cost savings and efficiency gains. The Associate Director will actively run trial, country, and site-level tasks, coordinate financial responsibilities including purchase orders and invoice management, and develop methods to measure satisfaction. They will monitor site contacts and KPIs to ensure compliance with Lilly Standards and regulatory requirements, generate and revise site documents, and influence vendors to develop strong partnerships with investigators and site staff. Additionally, the role involves leading internal relationships across various internal departments and serving as a resource for local regulations, quality systems, and GCP.
Develops and delivers prescription medicines globally
Eli Lilly and Company is a global pharmaceutical company that focuses on discovering, developing, and delivering medicines to improve health. The company has a long history of scientific achievements, including the creation of insulin, the first life-saving treatment for diabetes. Lilly's operations involve extensive research and development to create new medications and enhance existing ones, ensuring they are safe and effective. Their products are primarily prescription medicines sold to healthcare providers for various medical conditions, including diabetes, cancer, and pain management. What sets Lilly apart from its competitors is its strong commitment to ethical practices and the protection of its products from counterfeiting. The company's goal is to enhance lives through innovative medical solutions while maintaining high standards of quality and ethics.