Lilly Global Business Operations Budget Consultant – Trial Capabilities in Indianapolis, Indiana
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 Global Business Operations Trial Capabilities Budget Consultant will provide leadership in clinical trial capabilities as it pertains to the Clinical Investigator budget both in support of clinical development and study budget design. The consultant will provide Global support to Trial Capabilities Associates, Regulatory Agencies, institutions and investigators navigating complexities with site budgets, contracts, patient reimbursement, and other budget related items for clinical trials. Through synergetic partnerships, accurate planning and on-time execution, the consultant will aid in accomplishing all country and site level trial expectations.
Provide expertise related to budget processes and identify strategic levers to obtain cost savings and efficiency gains.
Design, execute and improve budget capabilities critical to the success of the organization.
Develop and coordinate country and site level activities during startup, maintenance, and close out including supporting the development of global, country and site budgets by partnering with cross functional organizations.
Partner with Global budgeting team to evaluate Lilly Fair Market Value (FMV) standards along with standard pricing, annually.
Lead and be a resource for others on local regulations, laws, and guidance (e.g., FDA, ICH), Quality and Business Systems, and Good Clinical Practices (GCP) to achieve inspection readiness and detect and resolve quality issues.
Support Global Site Investigator Fair Market Budget exceptions both the review and approval, in accordance with Authority delegated by Regulatory Legal and Procurement.
Develop strong collaboration with entire and Asset Team members who will engage in site activity and performance at site feasibility discussions during the life of the trial.
In relation to the investigator site budget, understand the financial responsibilities such as purchase order creation, management, and Purchase 2 Pay processes related to payments. At the global level, understand the life cycle of clinical site payment administration from protocol schedule of activities, database build through to payment execution.
Apply problem-solving skills and optimally partner with institutions, investigators, and cross-functional study team to resolve issues ensuring solutions meet regulatory and internal requirements.
Strategize, communicate, and execute site and country level risk mitigation and contingency plans for budget negotiations.
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 built, maintained, and governed for each process.
Provide business process guidance and tools to Lilly business partners and Third Party Organizations.
Continuously maintain a state of inspection readiness. Take part and perform duties required for internal and external inspections as well as supporting institutions and investigative sites in inspection readiness initiatives.
Minimum Qualification Requirements:
- Bachelor’s degree and 5 years of experience in clinical research
Other Information/Additional Preferences:
At least 3 years of clinical trial budgets experience is highly desired
Experience in coaching and mentoring others
Understanding of the overall clinical development paradigm and the interdependencies of the various tasks/functions/systems
Applied knowledge of project management processes and skills
Appreciation of / experience in compliance-driven environment
Knowledge of and ability to follow financial and legal guidelines and policies (budget and contract)
Strong communication, negotiation, and problem-solving skills
Self-management and organizational skills
Organizational change agent
Knowledge regarding National Comprehensive Cancer Network (NCCN) and Standard of Care.
Solid understanding of Centers for Medicare & Medicaid Services
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 ( LillyRecruitingCompliance@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 is an EEO/Affirmative Action Employer and 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.
As a condition of employment with Eli Lilly and Company in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide valid proof of vaccination to the company.
At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!