Budgets & Contracts Associate - Trial Capabilities at Eli Lilly and Company

Indianapolis, Indiana, United States

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

Bachelor’s degree preferably in a scientific or health related field
Two years clinical research experience or relevant experience preferred
Qualified candidates must be legally authorized to be employed in the United States (Lilly does not anticipate providing sponsorship for employment visa status, e.g., H-1B or TN status)

Responsibilities

Initiate investigator activities, including collection and submission of regulatory documents, customization and negotiation of informed consent documents
Serve as the point of contact for an investigator’s ERB and Competent Authority (CA) (where applicable)
Communicate and negotiate budgets with investigator personnel and internal teams
Negotiate and obtain fully-executed contract
Track and ensure investigator (and/or delegate) compliance to required training
Track and ensure investigator (and/or delegate) access to required clinical systems and supplies
Effectively drive timelines aligned with company priorities
Communicate directly with investigators (and/or delegates) to enable start-up and maintain an active collaboration during maintenance and close-out
Identify, communicate, and resolve issues
Ensure country specific regulatory and data privacy requirements are incorporated into submission documents and any other documents/systems
Leverage previous investigator / review board engagements to efficiently drive new work
Populate internal systems to ensure accuracy of trial / investigator performance
Understand and comply with procurement, legal and financial requirements and procedures
Populate Trial Master Files and libraries for future reference
Provide feedback and shared learning for continuous improvement
Leverage trial prioritization
Anticipate and monitor dynamically changing priorities
Coordinate investigator grant responsibilities such as purchase order creation, management, and P2P processes related to payment execution and/or reporting
Lead collection efforts for advanced and overpayments and ensure financial reconciliation required for studies for CRF payments and invoiced deliverables are effectively completed

Skills

Clinical Trials

Budget Execution

Contract Negotiation

Regulatory Documents

Informed Consent

Trial Master File

Ethics Approvals

Investigator Grants

Inspection Readiness

Eli Lilly and Company

Develops and delivers prescription medicines globally

About Eli Lilly and Company

Eli Lilly and Company is a global pharmaceutical company that focuses on discovering, developing, and delivering medicines to improve health. The company has a long history of scientific achievements, including the creation of insulin, the first life-saving treatment for diabetes. Lilly's operations involve extensive research and development to create new medications and enhance existing ones, ensuring they are safe and effective. Their products are primarily prescription medicines sold to healthcare providers for various medical conditions, including diabetes, cancer, and pain management. What sets Lilly apart from its competitors is its strong commitment to ethical practices and the protection of its products from counterfeiting. The company's goal is to enhance lives through innovative medical solutions while maintaining high standards of quality and ethics.

Indianapolis, IndianaHeadquarters

1876Year Founded

$1,180.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Competition from Novo Nordisk's Ozempic may impact tirzepatide's market share.

Potential construction delays in Indiana could affect GLP-1 drug production timelines.

Regulatory challenges may hinder Kisunla's expansion in new Alzheimer's markets.

Differentiation

Eli Lilly's rich history includes the first life-saving insulin treatment.

Lilly's strategic partnerships enhance its position in neurodegenerative disease treatments.

FDA approval of Zepbound opens new therapeutic markets for sleep disorder treatments.

Upsides

Lilly's $9 billion complex in Indiana boosts GLP-1 drug production capacity.

Kisunla's approval in China expands Lilly's Alzheimer's treatment market in Asia.

Collaboration with EVA Pharma enhances Lilly's reputation as socially responsible.

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