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.
The Trial Capabilities Lead provides clinical trial capabilities in support of clinical development. The Lead is accountable to ensure the investigator sites meet requirements to enroll study participants into clinical trials and support ongoing activities during site maintenance and closeout.
The Lead 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 Lead will provide local support to complement the centralized activities performed by Asia Pacific Trial Capabilities Centre to ensure compliance with local requirements/needs.
The Lead 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:This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.
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).
In addition to the above responsibilities, the Lead will have the below responsibilities:
Coordinate the execution of clinical trial across country/region for high priority (Game Changer, Potential Game Changer) trials. Provide consultation for effective communication with the regulatory agency (RA), ERB and relevant parties in addressing any validation questions on the clinical trial dossiers and resolving any barriers to approval including defining strategy for submission. Be able to represent the study team opinion or rationale.
Lead and be a resource for others on local regulations, laws, and guidance (e.g., ICH), review any changes to local regulations, assessing the impact on local and global processes and ensuring implementation to meet regulatory requirements.
Collaborate with all applicable customers on process improvement projects by providing expertise and direct support to ensure completion and implementation. Develop and execute clear implementation and communication plans for new or revised processes. Ensure appropriate training and procedures are created, maintained, and governed for each process.
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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