Manager - Trial Capabilities

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.

Preferred Skill:

- Experience with clinical trials in Australia, India, Taiwan and other countries.
- Experience in project management skills or clinical trial start-up
- Local Applicant or foreigner with spouse visa

The Manager - Trial Capabilities:

- Coordinate the execution of clinical trial across country/region for high priority 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.

The Trial Capabilities manager provides clinical trial capabilities in support of clinical development.
- 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.
- 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.
- will provide local support to complement the centralized activities performed by Asia Pacific Trial Capabilities Centre to ensure compliance with local requirements/needs.
- 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.
- if assigned to Clinical Trial Payment, the role is to manage clinical trial investigator payments and other financial transactions related to investigator site readiness, maintenance and close out. Additional responsibilities include the support to budget and agreement in relation to clinical trial payment.
- may line manage or supervise junior direct reports (2-5 staff)

Additional Preferences:

- Previous clinical trial experience or relevant experience preferred (at least 5 years).
- Bachelor’s degree preferably in a scientific or health related field
- 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.

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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