Associate Director - Central Clinical Services

About Lilly

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.

About Clinical Central Services and Innovation (CCSI)

The Clinical Central Services and Innovation (CCSI) organization is responsible for strategically planning and supplying materials, trial support services and innovative capabilities to support the execution of clinical trials globally for all business units across all phases of development. This group is within the Clinical Capabilities organization and partners across functions within the CDDA and PRD to influence trial design and provide solutions to operationalize these trials and enable asset strategies across the portfolio.

Associate Director of CCSI Responsibilities

The Associate Director of CCSI is passionate about delivering the implementation of clinical capabilities including but not limited to mobile health care, telemedicine, virtual trial orchestration, recruitment & retention, new site models, central services and/or digital devices. This role will also be responsible for vendor management to support the capabilities.

Central Clinical Services

• Ensure vendors deliver education and lead studies and partner screening and consenting.
• Supervise vendors in initiating and handling all assessment scheduling, logistics, technology, and communication for partners, central raters, investigators, and other study-related entities including MRI centers and infusion centers, where applicable.
• Ensure vendors maintain all study documentation and data entry into applicable technology solutions.

Process Optimization

• Contribute to process optimization.
• Lead decisions across studies and across vendors that impact operations.
• Make decisions in the best interest of the participant, partner, investigator and/or other site staff to drive improved experiences and optimal efficiency.
• Serves as expert and influences complex business and technical decision and process improvements.
• Supervise the vendor partner day to day operations and provide mentor and training, as vital.
• Provide expertise related to budget processes and identify strategic levers to acquire cost savings and efficiency gains.

Trial Execution and Financial Management

• Actively run trial, country and site-level tasks ensuring all study assessments are completed with the highest quality and within protocol parameters.
• Coordinate financial responsibilities including purchase order creation, invoice management, study-specific center payments and payment reconciliation.

Performance Monitoring and Documentation

• Develop and implement methods, mechanisms, and tools to meet and measure investigator, participant, partner, and vendor satisfaction.
• Monitor site contacts (e.g., calls, written communication, etc.) and KPIs (key performance indicators), to ensure CCS is in accordance with Lilly Standards (Patient Safety, Medical Quality, privacy etc.) and external and regulatory requirements.
• Generate, revise and train CCS team on site documents (e.g., operational manual, FAQ document, etc.).

Relationship Management and Compliance

• Influence vendors to develop strong partnerships with Investigators, and other site staff.
• Lead internal relationships across the CDDA (Trial Capabilities, Investigator Engagement, Patient Engagement, Clinical Design, Clinical Development, Asset Team, CCSI, CLS, SD&A).
• Lead and be a resource for others on local regulations, laws, and guidance (e.g., FDA, ICH), Quality and Business Systems, and Good Clinical Practices (GCP) to achieve inspection readiness and detect and resolve quality issues.
• Apply problem-solving skills and effectively partner with institutions, investigators, and cross-functional study team to resolve issues ensuring solutions meet regulatory and ICH/GCP requirements.