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.
Purpose:
The Trial Capabilities Associate provides 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 is responsible for obtaining clinical trial authorizations and ethical approvals, execution of the budget and contract, and activities related to clinical finance, record management and site training. The Associate will provide local support to complement the centralized activities performed by Asia Pacific Trial Capabilities Centre 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.
Primary Responsibilities:
Clinical Trial Responsibilities
Initiate investigator site activities, including collection and submission of regulatory documents, customization and negotiation of informed consent documents, serve as the point of contact for a site’s ethics review board (ERB) and competent authority (CA) (where applicable), communicate and negotiate budgets with site personnel and internal teams, negotiate and obtain fully-executed contract, track and ensure site compliance to required training, and effectively drive timelines aligned with company priorities.
Communicate with sites to enable start-up and maintain an active collaboration with sites during maintenance and close-out.
Communicate with Clinical Design, Delivery and Analytics (CDDA) functions and external party / clinical research organization to enable active collaboration during site activation, maintenance, and close-out.
Ensure country specific regulatory and data privacy requirements are incorporated into submission documents and any other documents/systems.
Identify, communicate, and resolve issues. Escalate issues to aligned management and quality as appropriate.
Coordinate the management and delivery of clinical trial material to ensure support of site initiation.
Coordinate translation process for clinical trial documents and oversight of translation quality.
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 guidance, Lilly Medical policies and procedures, and Good Clinical Practice (GCP).
Qualifications & Experience
Bachelor’s degree in a scientific or health-related field (advanced degree or PhD preferred).
Prior exposure to clinical trials or related areas is preferred.
Proven experience in leading tasks and/or teams, with the ability to guide others toward successful project delivery.
Innovative mindset with the ability to adapt quickly to changing priorities and support tasks across multiple countries.
Knowledge & Skills
Solid understanding of the overall clinical development process, with emphasis on the importance of efficient site activation.
Applied knowledge of project management principles, tools, and techniques.
Familiarity with working in a compliance-driven environment, with strong appreciation for quality and regulatory requirements.
Preferred Attributes
Strong attention to detail, organizational skills, and ability to manage multiple priorities.
Effective communication and collaboration skills to work cross-functionally in a global team setting.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and 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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