Job Description

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 35,000 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.

The purpose of the Trial Capabilities Associate role is to provide clinical trial capabilities in support of clinical development. The Associate is accountable to ensure the investigator sites meet requirements to enroll study participants into clinical trials and support ongoing activities during site maintenance and close-out. The Associate provides local support to complement the centralized activities performed by Asia Pacific Trial Capabilities Centre (AP TCC) to ensure compliance with local requirements/needs. The Associate will ensure inspection readiness at all times following GCP; any local/regional requirements and Lilly operating procedures and through a complete, accurate and readily available Trial Master File (TMF) as per defined TMF document ownership. Additional local responsibilities may be required as needed/appropriate for the local geography and/or to cover regional differences.

Clinical Trial Responsibilities

• Initiate investigator site activities in collaboration with Asia-Pacific Trial Capabilities Centre personnel, including monitoring of clinical trial regulations and requirements, providing consultation for effective communication with the Ethics Review Boards (ERBs), Competent Authority (CA) and relevant parties in addressing any validation questions on the clinical trial dossiers and resolving any barriers to approval.
• Communicate and negotiate budgets with site personnel and internal teams, negotiate and obtain fully-executed contract
• Serve as the local point of contact for Trial Capabilities-related activities that have to be managed locally. The activities include, but not limited to meeting with site, ERB and CA for trial-related discussion; communicate with Site Engagement and external party / clinical research organization to enable active collaboration during site activation, maintenance and close-out
• Manage ERB/CA submission and site readiness activities involving distribute and collect hard-copy documents.
• Manage investigator payments and any other financial transactions related to Trial Capabilities which include, but not limited to, country/site budget tracking, and payment-related issue resolution
• Identify, communicate, and resolve issues
• Ensure country specific regulatory and data privacy requirements are communicated to Asia Pacific Trial Capabilities personnel for incorporation into submission documents and any other documents/systems
• Escalate issues to aligned management and quality as appropriate
• Coordinate the management and delivery of clinical trial material to ensure support of site initiation
• Populate internal systems to ensure accuracy of trial / site performance
• Populate Trial Master Files and libraries for future reference
• Provide feedback and shared learning for continuous improvement
• Anticipate and monitor dynamically changing priorities
• Understand and comply with procurements, legal and financial requirements and procedures
• Understand, comply, and reinforce local regulations and guidances, Lilly Medical policies and procedures, and good clinical practices (GCP)

Other requirements:

• Understanding of the overall clinical development paradigm and the importance of efficient site activation
• Applied knowledge of project management processes and skills
• Appreciation of / experience in compliance-driven environment
• Ability to learn and comply with financial and legal guidelines and policies (budget and contract)
• Effective communication, negotiation, and problem-solving skills
• Self-management and organizational skills
• Language Capabilities - English (read, write, conversation) and local language, as applicable

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

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.

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