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 country-based 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:
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).
Minimum Qualification Requirements:
Bachelor's degree preferably in a scientific or health related field.
At least one year clinical research experience or relevant experience preferred.
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 fast moving and compliance-driven environment.
Ability to learn and comply with financial and legal guidelines and policies (e.g.
budget and contract).
Effective communication, negotiation, and problem-solving skills.
Self-management and good organizational skills.
Able to multitask.
Agile and adaptable fast to changes with positive mindset.
Language Capabilities – English (read, write, conversation) and local language, as applicable.
Computer literacy – familiar with MS Words and Excel.#J-18808-Ljbffr