Sr. Associate -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.

Job Description Overview

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Purpose

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.

The Associate is focused on 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.

Responsibilities: Central Clinical Services

• Oversee direct communication and management of activities and assessments conducted by TPO staff for potential participants, and study partners, including screening, consenting and education.
• Ensure TPO deliverables for participant and partner screening and consenting are met providing oversight and guidance as needed.
• Monitor and manage the scheduling, logistics, technology and communication for participant/partner assessments, central raters, investigators, and other study-related entities including MRI centers and infusion centers, outsourced to vendors.
• Ensure vendors have all necessary study documentation and accurately enter data into applicable technology solutions.
• Make decisions that optimize the study experience for participants, partners, investigator and site staff balancing efficiency and quality.
• Prioritize daily work tasks to ensure timely and effective completion of responsibilities.
• Identify, communicate, and resolve site and study issues in collaboration with the Central Clinical Services capability, leveraging problem-solving skills and expertise.
• Serves as topic area expert, providing guidance and support to the team and stakeholders.
• Collaborate with the team to develop solutions to more complex related-study problems and drive process improvements.
• Provide oversight to vendors conducting site and partner/participant activities throughout all study timepoints, ensuring compliance and quality.
• Build and maintain strong investigator relationships with vendors, study sites, investigators and Lilly functions to enable an exceptional study experience.

Responsibilities: Organizational Leadership and Process Improvement

• Provide feedback and shared learning for continuous improvement.
• Manage tasks daily to ensure study assessments and activities are completed on time and with the highest possible quality.
• Ensure all requested and required guides are followed, documentation is maintained, and trackers/systems are up to date daily.
• Establishes relationships to enable study level work both externally and internally.
• Manage satisfaction of participants/partners.